Needle tip guard for percutaneous entry needles

ABSTRACT

A needle tip protective device for use with percutaneous entry needles. In one embodiment, the needle tip protective device includes a needle guard slidably mounted on a hypodermic needle, the latter having a needle tip located at the distal end thereof, and a change of profile formed medially there along. The needle guard is movable along the hypodermic needle and engageable with the change in profile formed thereon. The engagement with the change in profile is configured to correspond with the ability of the needle trap to entrap the needle tip once the needle trap has advanced the sufficient distance distally along the hypodermic needle. In further refinements, the needle trap may be biased toward the distal needle tip of the needle.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is related to and claims the benefit of filing dates ofthe following U.S. Non-Provisional patent applications: (1) Ser. No.60/012,343, entitled PROTECTED HYPODERMIC NEEDLE WITH AUTOMATIC ANDMANUAL COVERING MEANS, filed Feb. 27, 1996; (2) Ser. No. 60/025,273,entitled HYPODERMIC DEVICES WITH SAFETY FEATURES, filed Sep. 12, 1996;and (3) Ser. No. 60/031,399, entitled HYPODERMIC DEVICES WITH IMPROVEDSAFETY FEATURES, filed Nov. 19, 1996; (4) U.S. patent application Ser.No. 807,328 entitled NEEDLE TIP GUARD FOR HYPODERMIC NEEDLES, now issuedas U.S. Pat. No. 5,879,337; (5) U.S. patent application Ser. No.09/172,185 entitled INTRAVENOUS CATHETER ASSEMBLY, now issued as U.S.Pat. No. 6,001,080, filed on Oct. 13, 1998; and U.S. patent applicationSer. No. 09/144,398 entitled NEEDLE TIP GUARD FOR HYPODERMIC NEEDLES,filed on Aug. 31, 1998, the teachings of which are expresslyincorporated here and by reference.

BACKGROUND OF THE INVENTION

The advent of Human Immunodeficiency Virus (HIV), combined with theincreasing incidence of other bloodborne pathogens such as Hepatitis BVirus (HBV) and Hepatitis C Virus (HCV), present healthcare workers withan occupational hazard unprecedented in modern medicine. The risk ofcontracting HIV from a needlestick injury is approximately 1 in 250, butfor those who contract HIV infection as a result of a needlestick injurythe risk becomes 1 in 1. The risk of contracting the more contagious HBVas a result of a needlestick injury ranges from 1 in 6 to 1 in 30.

There are also over twenty more known bloodborne pathogens which aretransmitted via blood and bodily fluids. The presence of any of thesepathogens in patients poses a risk to healthcare workers when invasiveprocedures are performed. Infectious diseases are now the third leadingcause of death, behind heart disease and cancer, signifying a growingneed for safer hypodermic equipment. Ten years ago, infectious diseaseswere classified as the fifth leading cause of death, they are now rankedthird. This increase of infectious disease is attributed mainly to theover-use of antibiotics and the growing availability of re-usable,hollow-bore hypodermic equipment.

As the population of infected individuals increases, more people will betreated by healthcare workers, further increasing the odds of diseasetransmission from patient to healthcare worker. Also, the use ofdisposable hypodermic equipment is increasing at approximately 7% perannum. Additionally, a meaningful number of clusters of patient topatient transmission in the healthcare setting has been identifiedthroughout the world. Early data suggests improper infection controltechniques contribute directly to this increase: including improper useof hypodermic equipment, multiple-dose medicine vials; and failure tochange protective gloves and gear for each new patient.

Recent studies also cite the discovery of significant bloodcontamination on re-usable blood collection vacuum tube holders whichare routinely used to collect blood from different patients. Commonpractice is to ship one vacuum tube holder with 100 blood collectionneedles. It is likely that new routes of disease transmission will alsobe found in the future. Healthcare workers are increasingly at risk todisease transmission and nurses perform the majority of invasivehypodermic procedures, such as injecting medicine, collecting blood andinserting indwelling intravenous (I.V.) catheters. Nurses and otherhealthcare personnel are routinely injured by the exposed, sharp lancetof the needle after use on a patient. The critical time where apercutaneous injury can occur is from the moment the needle is withdrawnfrom the patient, or I.V. port, to the time the contaminated needle issafety discarded.

There are approximately 5.6 million workers in the United States (U.S.)whose jobs place them at risk for sustaining an accidental needlestickinjury. Medical literature cites approximately one million reportedneedlestick accidents occur in the U.S. each year, with an additionaltwo-thirds believed to be unreported. One million injuries per yeartranslates to a needlestick injury, on average, every thirty-twoseconds. Prior to the proliferation of HIV and serum hepatitis, aneedlestick injury was considered a routine part of providing patientcare. A needlestick injury now carries a life-threatening consequenceand healthcare workers must live with this terror on a daily basis.

Hypodermic needles are used in a wide variety of invasive medicalprocedures with approximately 12 billion units being consumed on anannual basis. Basically, the great majority of hypodermic needles areintended for a single-use on an individual patient and are providedsterile in a variety of lengths and gauges. Hypodermic needles arenormally discarded after a single use into a specially designed,puncture-proof biohazard container.

Hypodermic needles are used in medicine, science, veterinary medicine,the biotechnology and pharmaceutical industries, and also in thechemical industry. Medical and veterinary uses range from injectingmedication or diluent into a patient or I.V. port, collecting blood,bodily fluids or specimens from patients and, preparing medication. Thebiotechnology and pharmaceutical applications mainly involve researchwhere substances, liquids, gases or compounds are injected, mixed orwithdrawn through a membrane or barrier into a specimen or controlledfield. Chemical industry applications involve injecting or removingsubstances, liquids, gases or compounds to or from a specimen orcontrolled field. In each and every instance, whether medical orindustrial, exposed needles pose a danger of injuring the user.

In medicine, in addition to the danger of contacting contaminated bloodor bodily fluids, highly reactive or toxic substances are used forchemotherapy or therapeutic purposes. In the biotechnology,pharmaceutical and chemical industries, toxic, highly reactive,corrosive materials or substances are combined or withdrawn from avariety of experiments or projects.

Despite all the obvious dangers associated with the use of exposedhypodermics, and the availability of manually activated safetyhypodermic devices, unguarded, exposed hypodermic needles still dominatethe marketplace. This is due to the common practice in the industrywhere exposed hypodermic needles are sold at discounted prices andusually come packaged with other medical equipment and supplies. Medicalinstitutions continue to purchase exposed hypodermics in this fashionsimply for economic reasons.

The basic problem with many of the present day safety hypodermic devicesis that they are meant to be manually activated, or in the language ofthe medical device industry, they are considered “active” devices. Theymay have safety shields, retractable needles, moveable sheaths or thelike; but they generally require the user to complete another procedureto facilitate engagement of the safety mechanism. Although there are anumber of retractable needle into syringe devices available, themanufacturing costs associated with these devices are prohibitivelyhigh.

What is needed is a low-cost safety hypodermic apparatus with auniversal application.

BRIEF SUMMARY OF THE INVENTION

It is therefore an object of this invention to provide a needle pointguard that effectively shields the sharpened distal tip of the needleafter use.

It is another object of this invention to provide a safety hypodermicapparatus which is automatic and/or semi-automatic covering, fail-safeand single-use in nature.

It is another object of this invention to provide a safety hypodermicapparatus which looks similar to a standard, exposed, disposablehypodermic needled device (i.e., the needle and needle tip are exposedprior to performing the hypodermic procedure).

It is another object of this invention to provide a safety hypodermicapparatus which conforms to existing procedures for aspiratingmedication into a syringe, administering injections, and allowingunrestricted access for vascular access or catheter insertion.

It is yet another object of this invention to provide a safetyhypodermic apparatus which provides an exposed sharpened tip forbevel-up needle viewing.

It is still another object of this invention to provide a safetyhypodermic apparatus which automatically and/or manually entraps orcaptures the sharpened tip of the needle after use.

It is a further object of this invention to provide a safety hypodermicapparatus which allows medication or diluent to be aspirated into asyringe without prematurely activating the automatic and/or manuallycovering safety mechanism.

It is a still further object of the invention to provide a safetyhypodermic apparatus which can be used with a double lancet needle forpiercing a cartridge in a pre-filled syringe, or a stopper in a bloodcollection vacuum tube.

It is an additional object of this invention to provide a safetyhypodermic apparatus which lends itself to automated manufacturing.

It is another object of this invention to minimize any mechanicalresistance or component fatigue inherent to the stored energy componentsof the invention when the hypodermic needle is stored.

It is yet another object of the invention to leave the delicate,sharpened needle tip untouched during assembly procedures, ensuring thesharpest needle tip possible to minimize any patient discomfort duringuse of the hypodermic device.

It is a further object of the invention to reduce the number ofcomponents to the lowest possible number needed to accomplish theintended task of providing acceptable, low cost, fail-safe, single-usehypodermic devices for the healthcare industry.

It is yet another object of the invention to prevent catheter separationfrom the catheter carrying device until the needle tip is safelycontained in a protective cover.

It is another object of the invention to provide a safety hypodermicapparatus that allows a protective cover to be used with long needles,such as epidural needles, spinal needles, or percutaneous entry needlesfor placing guidewires.

It is yet another object of the invention to provide a safety hypodermicapparatus that allows a protective cover to be used with needles thatinclude a change in axis at the distal tip, such as implanted portneedles, or needles with a “Huber” tip.

It is yet a further object of the invention to provide a safetyhypodermic apparatus that allows a protective cover to be used withstraight needle shafts, or bent needle shafts that include a change inaxis at the distal tip, such as implanted port, needles or needles witha “Huber” tip.

It is yet another object of the invention to provide a safety hypodermicapparatus that includes a deformable retaining means for retaining andselectively releasing a protective member or cover.

It is another object of the invention to provide a safety hypodermicapparatus that includes a deformable retaining means that may be anintegral part of a needle hub.

It is a further object of the invention to provide a safety hypodermicapparatus that includes a deformable retaining means that may beretrofitted to an existing needle hub.

It is another object of the invention to provide a safety hypodermicapparatus that includes a deformable retaining means that may include agripping means.

In one embodiment the needle guard assembly of the present inventionincludes a needle guard that is slidably mounted on a hypodermic needlehaving a needle tip located at the distal end of the needle. The needleguard contains a movable needle trap that is biased against or towardthe hypodermic needle. The needle trap advances over the tip of theneedle, entrapping the needle tip as the needle guard is urged forwardnear the sharpened distal end of the hypodermic needle. A tether, orother limiting means, limits the forward movement of the needle guardalong the needle. In one embodiment, the needle guard is manually urgedforward along the shaft of the needle by the user. In yet anotherembodiment, a spring, or other biasing means, is used to move the needleguard along the shaft of the needle.

In another embodiment, a hypodermic needle is attached to a housing orhub. A coil spring is positioned between the hub, or housing, and theneedle guard assembly. The spring provides the biasing force foradvancing the needle guard assembly forward along the shaft of theneedle. Prior to use, the needle guard assembly is releasably retainednear the proximal end of the needle by a latching arm that is attachedto the hub or housing. In one embodiment, the latching arm isautomatically disengaged from the needle guard when a longitudinalcompressive force is exerted on the retained needle guard. In yetanother embodiment, the latching arm may be disengaged manually by theuser.

In another embodiment, a hypodermic needle is attached to a housing orhub. A coil spring is positioned between the hub, or housing, and theneedle guard assembly. The spring provides the biasing force foradvancing the needle guard assembly forward along the shaft of theneedle. Prior to use, the needle guard assembly is releasably retainednear the proximal end of the needle by at least one protrusion that isselectively inserted into at least one aperture on a deformable memberor housing. The needle guard is selectively released by squeezing thehousing and expanding the housing diameter at the retaining interface toallow the protrusion to disengage from the aperture on the housing.

In another embodiment, a side-loadable needle guard assembly is providedthat permits the needle tip protective device to be assembled withoutdisturbing the delicate sharpened needle tip. In one embodiment theside-loadable needle guard assembly includes a slotted configuration. Inyet another embodiment, the side-loadable needle guard assembly includesa “clam-shell” configuration.

In yet another embodiment, the needle guard assembly includes a couplingmechanism that prevents a mechanical separation from the catheter untilthe needle tip is safely contained within the needle trap. In oneembodiment, the coupling mechanism includes an arm having a proximal endand a distal end. The proximal end of the arm is attached to the movableneedle trap. The distal end of the arm includes a projection that isreleasably retained within a recess of a catheter hub. Hence, as theneedle trap moves inward to entrap the needle tip, the arm also movesinward. The inward movement of the arm causes the arm's distalprojection to be released from the catheter hub recess, therebypermitting a separation between the needle guard assembly and thecatheter hub.

Other objects and benefits of this invention will become apparent fromthe description which follows hereinafter when read in conjunction withthe figures that accompany it.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a full side view of a prior art hypodermic needleattached to a hub.

FIG. 2 is a front view of the hypodermic needle hub shown in FIG. 1.

FIG. 3A is a full side view of the hypodermic needle hub shown in FIG.1.

FIG. 3B is a full top view of the hypodermic needle hub shown in FIG. 1.

FIG. 4 is a cross sectional view of the hypodermic needle hub shown inFIG. 1.

FIG. 5 is a full side view of a hub in accordance with one embodiment ofthe present invention.

FIG. 6 is a cross sectional view of the hub shown in FIG. 5.

FIG. 7 is a cross sectional view of the hub shown in FIG. 5 having aflange section for retaining a removable cover.

FIG. 8 is a full side view of the hub shown in FIG. 7 with the additionof a protrusion for engaging a removable cover.

FIG. 9 is a full rear view of the needle hub shown in FIG. 7.

FIG. 10 is a full front view of the hub shown in FIG. 7.

FIG. 11 is a full front view of a needle guard assembly in oneembodiment of the present invention.

FIG. 12 is a full front view of the needle guard assembly shown in FIG.11.

FIG. 13 is a full outside view of a needle guard assembly and tether inone embodiment of the present invention.

FIG. 14 is a full side view of one embodiment of the present inventioncomprising a unitary construction.

FIG. 15 illustrates one embodiment of the present invention in aready-to-use state.

FIGS. 16-18 illustrate the needle guard assembly being activated tocover the tip of a hypodermic needle.

FIGS. 19-22 illustrate other embodiments of the present invention.

FIG. 23 illustrates another embodiment of the present invention.

FIGS. 24 and 25 show the present invention attached to a bloodcollection device.

FIG. 26 shows the present invention included in a catheter device.

FIG. 27 shows the present invention unitarily attached to a syringe.

FIGS. 28 and 29 show a needle guard in accordance with one embodiment ofthe present invention.

FIG. 30 shows a needle trap that is biased against or towards thehypodermic needle.

FIG. 31 shows a needle entrapped within a needle guard assembly in oneembodiment of the present invention.

FIG. 32 illustrates a tether in one embodiment of the present invention.

FIG. 33 illustrates a needle trap in one embodiment of the presentinvention.

FIG. 34 is a full open view of a needle guard assembly in one embodimentof the present invention

FIG. 35 is a exploded view of one embodiment of the present invention.

FIG. 36 is an isometric open view of the needle guard shown in FIG. 34.

FIG. 37A shows the needle tip guard assembly of FIG. 35 in a ready touse state.

FIG. 37B shows the needle tip guard assembly of FIG. 37A after it hasbeen activated.

FIGS. 38A and 38B show a needle tip protective device attached to afillable syringe in a ready-to-use and shielded position, respectively.

FIGS. 39A and 39B show a needle tip protective device attached to aprefilled syringe in a ready-to-use and shielded position, respectively.

FIGS. 40A and 40B show a needle protective device attached to aprefilled cartridge.

FIGS. 41A and 41B show a needle protective device attached to a bloodcollection apparatus in a ready to use and shielded position,respectively.

FIGS. 42A and 42B illustrate another embodiment of the presentinvention.

FIG. 42C illustrates a needle guard assembly in one embodiment of thepresent invention.

FIGS. 43A and 43B show separate embodiments of the needle guard assemblyof the present invention.

FIG. 44A illustrates another embodiment of the present invention.

FIG. 44B illustrates an enlarged cross-section view of the needle guardshown in FIG. 44A.

FIGS. 45A-C, 46 and 47 illustrate a needle hub in one embodiment of thepresent invention.

FIG. 48A-C illustrate several retrofit hub configurations in accordancewith the present invention.

FIG. 49A shows a full side view of the present invention attached to aprior art needle hub.

FIG. 49B is a cross-sectional view of FIG. 49A.

FIG. 50 is cross-sectional side view of the present invention attachedto a prefilled syringe.

FIG. 51 is cross-sectional side view of the present invention attachedto a prefilled cartridge syringe hub.

FIG. 52 is a cross-sectional side view of the present inventionsintergrally molded to a prefilled cartridge syringe hub.

FIG. 53 is cross sectional side view of a prior art I.V. catheteradapter.

FIG. 54 shows the present invention retrofitted to an I.V. catheteradapter.

FIG. 55 shows the present invention integrally molded to an I.V.catheter adapter.

FIG. 56 illustrates the present invention attachable to a bloodcollection device.

FIG. 57 illustrates a full front view of a needle guard assembly in oneembodiment of the present invention.

FIG. 58 is a cross sectional side view of a prior art prefilled syringecartridge hub.

FIG. 59 is a cross sectional side view of the present invention beingthreadedly attached to a glass cartridge hub.

FIG. 60 is a cross sectional side view of the present invention fixedlyattached to a glass cartridge.

FIGS. 61-63 illustrate a catheter in accordance with one embodiment ofthe present invention.

FIG. 64-67 illustrate another embodiment of the present invention.

FIG. 68 illustrates a full side view of another embodiment of thepresent invention.

FIGS. 69-77 illustrate a needle guard assembly in accordance with oneembodiment of the present invention.

FIG. 78 is a cross sectional side view of the present invention for useon a male luer syringe in a ready-to-use state.

FIG. 79 is a cross sectional side view of the present invention for useon a prefilled syringe or a prefilled cartridge syringe in aready-for-use state.

FIG. 80 is cross sectional side view of the hub and cover shown in FIG.78.

FIG. 81 is a cross sectional view of the needle and cover shown in FIG.79.

FIGS. 82 and 83 illustrate a collar for use in one embodiment of thepresent invention.

FIG. 84 illustrates another embodiment of the present invention.

FIG. 85 illustrates yet another embodiment of the present invention.

FIG. 86 is a graph depicting the interaction of a resilient member and asliding member without a needle guard notch.

FIG. 87 is graph depicting the interaction of resilient member and asliding member with a needle guard notch.

FIGS. 88-94 illustrate a number of different embodiments of the presentinvention.

FIGS. 95 and 96 illustrates a full side view of a needle hub in oneembodiment of the present invention.

FIGS. 97-102 show the embodiments of FIGS. 50, 51, 52, 54 and 55 with aneedle having a change in contour.

FIGS. 103-105 illustrate a catheter in yet another embodiment of thepresent invention.

FIGS. 106-108 show a cross sectional view of another embodiment of thepresent invention.

FIGS. 109-113 illustrate a side-loadable needle guard in one embodimentof the present invention.

FIGS. 114 and 115 show a needle guard assembly for use in a catheter.

FIGS. 116 and 119 show a needle trap in one embodiment of the presentinvention.

FIG. 117 is a full top view of a housing in one embodiment of thepresent invention.

FIG. 118 illustrates a cross sectional and cut-away view of a catheterintroducer in one embodiment of the present invention.

FIGS. 120 and 121 illustrate catheter assemblies in yet otherembodiments of the present invention.

FIGS. 122A-122C show an isometric view of a catheter in one embodimentof the present invention.

FIGS. 123 and 124 show a needle trap assembly for use in a catheter.

FIGS. 124-130 illustrate a needle guard in yet another embodiment of thepresent invention.

FIG. 131 illustrates a needle having an expanded change in profile nearthe sharpened tip.

FIG. 132 illustrates a needle having a reduced change in profile nearthe sharpened tip.

FIG. 133 illustrates a needle having an expanded change in profile nearthe sharpened tip limiting axial movement of a washer or bushing.

FIG. 134 illustrates a cross sectional view of the needle and washershown in FIG. 133.

FIG. 135 illustrates a washer shown in FIGS. 133 and 134.

FIG. 136 illustrates an entrapped needle having a change in profilelimiting the axial movement of a needle guard assembly that includes awasher or bushing in one embodiment of the present invention.

FIG. 137 illustrates an entrapped needle having a change in profilelimiting the axial movement of a needle guard assembly that includes aprotrusion to contain the needle within the needle guard.

FIG. 138 is a cross sectional front view of the needle and needle guardassembly shown in FIG. 137.

FIG. 139 is a full front view of a needle guard assembly having a splitline that is off set.

FIG. 140 is a full side view of a needle having a bend in the shaft, orchange in axis, near the distal tip.

FIG. 141 is a cross sectional side view of a needle shown in FIG. 140with a sliding cover being limited in movement by the change in axis ofthe needle shaft.

FIG. 142 is a cross sectional side view of a needle shown in FIG. 140with a sliding bushing being limited in movement by the change in axisof the needle shaft.

FIG. 143 is a cross sectional side view of a needle guard assemblyhaving a needle trap that is biased against or towards the hypodermicneedle having a change in axis.

FIG. 144 shows a needle entrapped within a needle guard assembly shownin FIG. 143.

FIG. 145 illustrates a full side view of a needle hub having adeformable member or housing.

FIG. 146 illustrates a full front view of the needle hub shown in FIG.145.

FIG. 147 illustrates a full top view of a needle hub having a deformablemember or housing shown in FIG. 145.

FIG. 148 illustrates a full top view of a needle guard apparatus of thepresent invention shown in a ready to use state having a needle guardbeing releasably retained in a needle hub having a distal deformablemember or housing shown in FIG. 147.

FIG. 149 illustrates a full front view of a needle guard assembly withan off set split line shown in one embodiment of the present invention.

FIG. 150 illustrates a full front view of the needle guard assembly ofFIG. 148 being retained in a deformable housing shown in one embodimentof the present invention.

FIG. 151 illustrates a full front view of a needle guard assembly ofFIG. 150 being selectively released by compressing and deforming thehousing.

FIG. 152 illustrates an isometric view of a needle tip guard assemblybeing retained in a deformable member or housing in a ready to usestate.

FIG. 153 shows the needle tip guard assembly of FIG. 152 after it hasbeen activated.

DETAILED DESCRIPTION OF THE INVENTION

A needle tip protective device is described. In this regard, to theextent applicable, this application is related to and claims the benefitof filing dates of the following U.S. Non-Provisional patentapplications: (1) Ser. No. 60/012,343, entitled PROTECTED HYPODERMICNEEDLE WITH AUTOMATIC AND MANUAL COVERING MEANS, filed Feb. 27, 1996;(2) Ser. No. 60/025,273, entitled HYPODERMIC DEVICES WITH SAFETYFEATURES, filed Sep. 12, 1996; and (3) Ser. No. 60/031,399, entitledHYPODERMIC DEVICES WITH IMPROVED SAFETY FEATURES, filed Nov. 19, 1996;(4) U.S. patent application Ser. No. 807,328 entitled NEEDLE TIP GUARDFOR HYPODERMIC NEEDLES, now issued as U.S. Pat. No. 5,879,337; (5) U.S.patent application Ser. No. 09/172,185 entitled INTRAVENOUS CATHETERASSEMBLY, now issued as U.S. Pat. No. 6,001,080, filed on Oct. 13, 1998;and U.S. patent application Ser. No. 09/144,398 entitled NEEDLE TIPGUARD FOR HYPODERMIC NEEDLES, filed on Aug. 31, 1998, the teachings ofwhich are expressly incorporated here and by reference. In the followingdescription, numerous specific details are set forth in order to providea thorough understanding of the present invention. However, it will beobvious to one of ordinary skill in the art that the invention may bepracticed without these specific details. In other instances, well-knownstructures and processing steps have not been shown in particular detailin order to avoid unnecessarily obscuring the present invention.Additionally, it should be noted that throughout this discussionreference will be made to a variety of hypodermic needle devices such asfillable syringes, prefilled syringes, prefilled cartridge syringes,blood collection devices, percutaneous entry needles, implanted portneedles and catheters. It is appreciated, however, that the presentinvention is not limited to these devices, and may be used in anyapplication where it is desirable to provide a protective covering atthe tip of a needle or other elongated object.

Also keep in mind that the needle covering invention disclosed herein inregard to an I.V. catheter can easily be adapted to all types of othercatheters where a needle may be used, including, but not limited to,neurological, urological, central venous, oximetry, thermodilution,PTCA, PTA, angiography, atherectomy, enlectrophysiology, suction andwound drainage, cardiovascular, pulmonary and spinal catheters. Theneedle covering invention described herein on a syringe can also beeasily adapted to a blood collection needle, or any other needles usedin invasive procedures, including, but not limited to, angiography,cardiovascular, ophthalmological, orthopedic, dentistry, veterinary,chemotherapy and arterial blood gas.

FIG. 1 is a full side view drawing of a prior art standard, exposedhypodermic needle 10, having a sharpened needle tip 11 at the distal endwith the opposite, or proximal end of the needle 10 attached to a hub12, with at least one flange 1 at the very proximal end for attachingthe needle hub 12 to a male luer fitting, a needle nest 4 at the distalend of the needle hub 12, for fixedly attaching the needle 10, and aplurality of fins 2 on the needle nest 4.

FIG. 2 is a full front view drawing of the prior art hypodermic needlehub 12 with an aperture creating a fluid/gaseous path to the hypodermicneedle, a needle nest 4 for fixedly attaching the hypodermic needle 10therein, with the needle nest 4 surrounded by a plurality of fins 2 anda plurality of flanges 1.

FIG. 3A is a full side view drawing of the prior art hypodermic needlehub 12 with at least one flange 1 for attaching the needle hub 12 to amale luer fitting, a needle nest 4 for fixedly attaching the needle (notshown here) and a plurality of fins 2.

FIG. 3B is a full top view drawing of the prior art hypodermic needlehub 12 with at least one flange 1 for attaching the needle hub 12 to amale luer fitting, a needle nest 4 for fixedly attaching the needle (notshown here) and a plurality of fins 2.

FIG. 4 is a cross-sectional view of the prior art hypodermic needle hubshown in FIG. 2 along axis 4-4 comprising a hub portion 12 with a flange1, an aperture creating a fluid/gaseous path to the hypodermic needle(not shown here), a needle nest 4 for fixedly attaching a hypodermicneedle (not shown here), and a plurality of fins 2.

FIG. 5 is a full side view drawing of the hub section of the disclosedinvention comprising a hypodermic needle hub 112 with at least oneflange 101 for attaching the needle hub 112 to a male luer fitting, aneedle nest 104 (not shown here) for fixedly attaching the needle (notshown in this view), an inner aperture creating a fluid/gaseous pathbetween the needle hub 112 and the needle (not shown here), a protrusion5 located at the distal end of the needle hub 112, the protrusion beingconnected to the extended sidewall section 15 at the distal end of theneedle hub 112, and a moveable latching arm 26 with a finger pad 27attached to the needle hub 112 by a hinge section 23, with the moveablelatching arm 26 having a protrusion 21 for retaining a component in areleasable position on the needle hub 112, said moveable latching arm 26shown in the preferred molded position.

FIG. 6 is a cross-sectional side view of FIG. 5. Needle hub 112 includesan inner aperture that provides a fluid/gaseous path between the needlehub 112 and the needle (not shown here). Arrow “M” indicates thedirectional movement of latch 26.

FIG. 7 is a cross-sectional side view of FIG. 5 having a section 16 forremovably holding a removable cover over the hypodermic needle.

FIG. 8 is a full side view of the hub 112 shown in FIG. 7, with theaddition of at least one protrusion 14 located adjacent to section 16,said protrusion 14 being engagable with a removable cover. Protrusion14, in conjunction with a contacting member of removable cover, ispositioned to facilitate attachment or removal of a hypodermic needlefrom a connecting device. Hub 112 also includes a protrusion or cleat 17with a cap or holding means 18 to attach a tether.

FIG. 9 is a full rear view of needle hub 112 shown in FIG. 7.

FIG. 10 is a full front view drawing of the disclosed hub inventioncomprising a hypodermic needle hub 112 with an extended wall section 15,an aperture creating a fluid/gaseous path to the hypodermic needle (notshown), a needle nest 104 for fixedly attaching the needle (not shown),a protrusion 5 which can be used as a guide for aligning anothercomponent, a section 16 for removably holding a removable cover over thehypodermic needle (not shown here), a protrusion 14 located adjacent tosection 16 for engaging a corresponding component of a removable cover(not shown), and a moveable latching arm 26 with a finger pad 27attached to the needle hub 112 by a hinge section 23 (not shown).

FIG. 11 is a full front view of a needle guard assembly 22 positioned onthe front of the hub 112 comprising a guide aperture 47 with ahypodermic needle 10 therethrough, said aperture 47 being created bycoupling the open-faced sections of the needle guard assembly 22together at a split line 43, a protrusion 5 which is used as a guide foraligning the needle guard assembly 22 on the hub 112 whereby an apertureis created on the needle guard assembly 22 when the open-faced sectionsof the needle guard assembly 22 are coupled together, a section 16 forremovably holding a removable cover over the hypodermic needle 10, aprotrusion 14 located adjacent to section 16 for engaging acorresponding component of a removable cover (not shown). In oneembodiment needle guard 22 also includes a moveable latching arm that isattached to needle hub 112 by a hinge section. A tether (not shown), isgenerally used to fixedly attach needle guard 22 to hub 112.

FIG. 12 is a full front view of the needle guard assembly 22 shown inFIG. 1I comprising a guide aperture 47 created by coupling theopen-faced sections of the needle guard assembly 22 together at thesplit line 43, a recess 25 with a protrusion 44 at the rear or inner endof the recess 25 i a tether 24 connected to a hinge section 28 and anaperture adjacent to the hinge section.

FIG. 13 is a full outside, top view of the needle guard assembly 22 andtether 24 as manufactured comprising an openfaced needle guard 22 with ahinge section 28, with adjacent lands 39 which create an aperture whenthe needle guard assembly 22 is coupled together, a needle tip guard 41with a hinge section 40 allowing the needle tip guard 41 to move, arecess 25 with a protrusion 44 and a tether 24 with a connector or loop20.

FIG. 14 is a full side view of a unitary, one piece embodiment of theinvention comprising a hypodermic needle hub 112, having at least oneflange 101, an extended wall section 15, a protrusion 5, a moveablelatching arm 26 connected to said hub 112 by a hinge 23, said latchingarm having a finger pad 27 at the proximal end and a hooking protrusion21 at the distal end, a protrusion 17 connecting a tether 24 to aslidable needle guard assembly 22, with a moveable needle tip guard 41and a hinge section 40. In addition to serving as an alignment guideneedle guard 22, protrusion 5 may also serve as an aspiration stop whena needle is inserted into a medicine vial.

FIG. 15 is a full side view of the invention shown in the ready to useconfiguration comprising a hypodermic needle 10 with a sharpened tip 11,a needle hub 112, with at least one flange 101, an extended sidewallsection 15, a section 16 for removably attaching a cover, a protrusion14 located adjacent to section 16, said protrusion 14 being engagablewith a removable cover, said protrusion 14 in conjunction withcorresponding member of removable cover, being positioned to facilitateattachment or removal of a hypodermic needle from a connecting device, amoveable latching arm 26 connected to hub 112 by a hinge 23, saidlatching arm having a finger pad 27 at the proximal end and a hookingprotrusion 21 at the distal end, said latching arm 26 releasably holdingsaid needle guard 22 and a compressed resilient member 19 in a retainedposition, said needle guard 22 having a moveable needle tip guard 41which is biasly contacting the hypodermic needle, a protrusion 5 on thehub 112 for aligning a needle guard assembly 22 to the needle hub 112 sothe moveable latching arm 26 properly enters the corresponding recess 25on the needle guard assembly 22, said needle guard assembly 22 beingconnected to said hub 112 by a tether 24.

FIG. 16 is a full side view FIG. 15 with a compressive longitudinalforce being exerted on the needle guard assembly 22, whereby the needleguard assembly 22 and compressed resilient member 19 move enough torelease the hold by the protrusion 21 of the moveable latching arm 26.

FIG. 17 is a full side view FIG. 15 with the released needle guardassembly 22 being urged to the distal end of the hypodermic needle 10 bythe extending force of the resilient member 19, said needle tip guard 41is biasly contacting said hypodermic needle 10 by the inherent memory ofthe molded configuration of said needle tip guard 41 and/or theextending force of the surrounding resilient member 19.

FIG. 18 is a full side view FIG. 15 with the resilient member 19extended and still exerting force on the needle guard assembly 22, saidresilient member 19 assists inherently molded bias of needle tip guard41 by urging said needle tip guard 41 inwardly and ahead of thesharpened needle tip, said needle guard assembly 22 is limited fromadvancing further by the extended tether 24, with the sharpenedhypodermic needle tip being entrapped within the needle guard assembly22, with the needle tip guard 41 now securely positioned ahead of thesharpened needle tip said needle tip guard 41 blocking the apertureguide of the needle guard assembly 22, ensuring safe containment of thesharpened tip.

FIG. 19 is a full bottom view of FIG. 15 showing the elements of theinvention and a rectangular finger pad configuration, although thefinger pad configuration only needs to be suitable (round, square,triangular or the like) to facilitate a manual force to release the holdon retained needle guard assembly 22, said needle guard assembly 22having a recess 25 for engaging the distal end of the movable latchingarm 26 to the corresponding section on the needle guard assembly 22.

FIG. 20 is a full top view of FIG. 15 showing the elements of theinvention and having a tether 24 which can have a round, square,elliptical or ribbon-like cross section and hinge section 28. It isimportant to note that the tether can comprise either rigid or flexiblecharacteristics, and can be unitary molded with other components, or bea separate component. A rigid tether would have to be able to slidealong the side of a syringe, prefilled syringe or cartridge, bloodcollection needle holder or I.V. catheter when the device is used, andsaid tether could slide through an aperture which would limit the axialforward movement of the tether and needle guard. This rigid tether wouldhave to have a proximal end larger than the aperture, so the tetherwould be limited in its slidable movement.

A flexible tether can be made more resilient or rigid by changing themolecular alignment of the molecules of the tether component bystretching, heating, radiation processing or the like. The tether can bemanufactured separately, or connected to either the hub component, theneedle guard assembly or the needle guard housing. The tether could becomprised from a single variety, or a combination of materialsincluding, but not limited to: plastic resin, synthetic material,organic material, cloth, woven material, stranded material, metal, silk,or a composite material.

FIG. 21 is a full side view of FIG. 15 having an extended protrusion 105for preventing premature release of the releasable needle guard assembly22. This embodiment can be used for blood collection purposes,indwelling catheter placement or preventing premature activation duringmedicine aspiration.

FIG. 22 is a full top view of FIG. 15 having an extended protrusion 105for preventing premature release of the releasable needle guard assembly22.

FIG. 23 is a cross-sectional view of the invention ready for use havingthe elements described herein, with the resilient member 19 in acompressed position with the needle guard assembly releasably held bythe protrusion 21 of the moveable latching arm 26, an aperture fororienting said needle guard assembly 22 adjacent to said hub portion112, and an aperture 47 with a hypodermic needle 10 therethrough, saidlatching arm 26 having a protrusion 49 for engaging said needle guardassembly 22 when said needle guard assembly is moved toward said hubportion 112, said protrusion 49 manually moves said latching arm 26 inan outward manner ensuring said latching arm 26 moves outwardlyreleasing the hold on the needle guard assembly 22.

FIG. 24 is a full side view of the invention for blood collectingpurposes showing the elements described and notated in the previousdrawings in addition to a double-lancet hypodermic needle 110 having asharpened tip 11 at the distal end and a sharpened tip 111 at theproximal end (see FIG. 25), a hub 212 having a threaded section forremovably attaching the hub into a needle holder 45 (see FIG. 25) bymeans of threads 74, and a piercable, collapsible cover 48 on the distalend of the needle 110 and a protrusion 105.

FIG. 25 is a full side view of the invention for blood collectingpurposes showing the elements described and notated in the previousdrawings in addition to the invention being removably attached to aneedle holder 45, said needle holder 45 having a larger opening at theproximal end for inserting a removable blood collection tube, and asmaller opening at the distal end for removably attaching a bloodcollection needle 110 and hub 212. A manual releasing means is activatedby pressing the finger pad 27 in a downward or inward manner, this isindicated by the arrow “F” pointing toward the finger pad 27.

It may be noted that the attachment means of connecting the invention toa blood collection needle holder 45 is not limited to the threaded means74 shown throughout this application. Other attachment means, such asfrictional engagement, snap fit, wedging or the like may also be used toaccomplish the same function.

FIG. 26 is a full side view of the invention with a removable,indwelling catheter, having a hub 312 attached to a hollow bore needle210 with a distal stylet 211 and a removable, indwelling catheter 51 andcatheter hub 50 slidably disposed on said needle 210. All other elementsnotated are described in the previous drawings.

FIG. 27 is a full side view of the invention in a ready to use stateunitarily attached to a syringe 6 by the hub 112. All other elementsnotated are described in the previous drawings.

FIG. 28 is a full front view of the needle guard assembly shown in anopen-faced configuration comprising a needle guard assembly 22 having ahinge section 28 joining each section, a split line 43 where thesections mate together, an aperture guide 47 on each section, a recess25 on one section having a protrusion 44 for joining with thecorresponding element 144 on the other section of said needle guardassembly 22, a moveable needle tip guard 41 and a post 36 for joiningthe needle guard assembly 22 sections together.

FIG. 29 is a full rear view of the needle guard assembly shown in anopen-faced configuration comprising a needle guard assembly 22 having ahinge section 28 joining each section, a split line 43 where thesections mate together, an aperture guide 47 on each section, aprotrusion 44 for joining with the corresponding element 144 on theother needle guard assembly 22 section, a moveable needle tip guard 41,at least one post or protrusion 36 on one needle guard assembly 22section which enters at least one corresponding slot 37 on the otherneedle guard assembly 22 section for securing the sections together.

FIG. 30 is a cross-sectional side view showing the interaction of theneedle guard assembly 22 with the resilient member 19 and hypodermicneedle 10 and sharpened needle tip 11, comprising a moveable needleguard assembly 22 with a hypodermic needle 10 therethrough, withresilient member 19 urging the needle guard assembly 22 toward thedistal end of the hypodermic needle 10. The needle guard assembly 22having a moveable needle tip guard 41 with a hinge section 40, saidneedle tip guard 41 is molded in a manner whereby the needle tip guard41 comprises an inherent biasing force toward the hypodermic needle 10,another biasing force is exerted on the needle tip guard 41 by theextending force of the resilient member 19, said needle tip guard 41enters the corresponding recess 31 when said needle tip guard 41advances beyond the sharpened needle tip 11, said needle tip guard 41slidably contacts said hypodermic needle 10. The needle guard 22 isattached to a hub element 12 by means of a tether 24 as described andnotated in the previous drawings.

FIG. 31 is cross-sectional side view showing containment of thesharpened needle tip 11 within the needle guard assembly 22 comprising aneedle guard assembly 22 with a hypodermic needle 10 therethrough, saidneedle guard assembly 22 being urged beyond the distal end of thehypodermic needle 10 and sharpened needle tip 11 by the extending forceof a resilient member 19 whereby the moveable, self-biasing needle tipguard 41 of the needle guard assembly 22 moves in front of the sharpenedneedle tip 11, containing the sharpened needle tip 11 within the needleguard assembly 22 and behind the substantially impenetrable needle tipguard 41 having a hinge section 40. Additionally, the extending force ofthe resilient member 19 urges the needle tip guard 41 inwardly to acovering position, said resilient member 19 surrounds both the needleguard assembly 22 and the outer wall of the needle tip guard 41 holdingthe needle tip guard 41 in a closed, protective position by a radiallyconfining force. In the protected, closed position, the needle tip guard41 enters the corresponding recess 31 of the needle guard assembly 22,preventing movement and ensuring safe containment of the sharpenedneedle tip 11 within the needle guard assembly 22. The needle guard 22is attached to a hub or housing by means of a tether as described andnotated in the previous drawings.

FIG. 32 is a full top view of a separate tether 24 with connecting loops20 at the proximal and distal ends. This tether embodiment is used witha separate hub component and separate needle guard assembly component.

FIG. 33 is a cross sectional side view of the needle guard assembly 22comprising a needle tip guard 41 having a hinge section 40 connected tothe needle guard assembly 22. Said needle tip guard 41 is molded in aself-biasing manner as shown and is moveable to an open and closedposition. Said needle tip guard may comprise a substantiallyimpenetrable plastic resin and/or a substantially impenetrable metal.

FIG. 34 is a full open view of the interior of the open-face needleguard assembly 22 as manufactured and before being joined together. Saidneedle guard assembly 22 comprising two joining sections which areconnected by a hinge section 28 having a tether 24, one needle guardassembly section having a moveable, self-biasing, substantiallyimpenetrable needle tip guard 41 with a moveable hinge 40 connected tosaid needle guard assembly 22, a post or protrusion 36, a recess 25 witha protrusion 44 and a recess 38 for nesting said needle guard assembly22 adjacent to the needle hub 112, 212 or 312 as shown in the previousdrawings; with the corresponding needle guard assembly section having acorresponding slot 31 for said needle tip guard 41 to enter, a slot 37for receiving the corresponding post 36, a proximal inner guide section35 and a distal inner guide section 47 for the hypodermic needle 10 (notshown), a corresponding receiving section 144 for recess 25 andprotrusion 44, and a recess 38 for nesting said needle guard assembly 22adjacent to the needle hub 112, 212 or 312 as shown in other drawingsherein.

FIG. 35 is a full, exploded view of the invention having the elementsdescribed herein the other accompanying drawings comprising a slidableneedle guard assembly 22 in the closed face configuration having atether 24 and loop 20; a resilient member 19; and a hypodermic needle 10fixedly attached the needle hub. FIG. 36 shows needle guard assembly 22in a full view, open-faced configuration. The open face, or “clam-shell”configuration of the needle guard make this embodiment feasible usingstandard injection molding techniques. The sharpened needle 10 is firstattached to the hub portion 112, then the needle 10 is coated with afriction-reducing lubricant, the resilient member 19 is concentricallydisposed over the needle 10 and compressed, then the needle guardassembly 22 is assembled from the side of the needle 10 keeping thesharpened tip 11 from being contacted, the needle guard assembly 22 andtether 24 are then attached to the hub 122 by a connecting means 20.

The extended wall section 15 can be eliminated for the invention towork, but shields the resilient member 19. The elements of the needleguard assembly 22, in relation to each other, and in relation to thebevel of the sharpened needle tip 11, can also be oriented as may bedeemed necessary to suit a specific procedure or purpose.

FIG. 37A is an isometric drawing of a needle tip protective device 500in one embodiment of the invention. FIG. 37A shows protective device 500in a ready-to use position. FIG. 37B shows the protective device 500shielding the needle tip within the needle guard assembly 22.

FIGS. 38A and 38B show a needle tip protective device 500 in oneembodiment of the invention attached to a fillable syringe 501 in aready-to-use position and a shielded position, respectively.

FIGS. 39A and 39B show a needle tip protective device 500 in oneembodiment of the present invention attached to a prefilled syringe 502in a ready-to-use position and a shielded position, respectively.

FIGS. 40A and 40B show a needle protective device 500 in one embodimentof the invention attached to a prefilled cartridge 503. FIG. 40A showsthe prefilled cartridge 503 before use. FIG. 40B shows the prefilledcartridge 503 after the protective device 500 is activated.

FIGS. 41A and 41B shows a needle protective device 500 in one embodimentof the invention attached to a blood collection device 504 in aready-to-use position and a shielded position, respectively.

FIG. 42A illustrates a needle tip guard assembly in yet anotherembodiment of the present invention for protecting the distal tip 11 ofa standard hypodermic needle 10. The assembly 20 includes a needle guard22 that is slidably mounted on needle 10. Needle guard 22 contains amovable needle trap 41 that is biased against or toward the shaft ofneedle 10. Needle trap 41 advances over the tip 11 of the needle 10,entrapping the needle tip 11, when needle guard 22 is positioned nearthe distal tip of needle 10. FIG. 42B shows distal needle tip 11captured within needle guard 22. In the embodiment of FIG. 42A, needleguard 22 is moved forward along the shaft of needle 10 by the user. InFIG. 42A, needle trap 41 is shown as a detachable element of needleguard 22 that is insertable into a slot 80 located adjacent the proximalend of needle guard 22. Needle trap 41 generally comprises a flexiblemetal member. Other impregnable materials that are not susceptible tofatigue may also be used. For example, some plastics or other resinbased materials may be used. In such instances, needle trap 41 may beintegrally molded with needle guard 22. A recess 31 may be includedwithin needle guard 22 for receiving needle trap 41. A flexible tether24 limits the forward movement of the needle guard 22 along the needle10. Other limiting means, such as, for example, a change in contour inneedle 10 or the use of a rigid tether assembly may be used in lieu ofthe flexible tether. These limiting devices will be described in greaterdetail later in this description.

FIG. 42C shows needle guard 22 a that is another embodiment of theneedle guard 22 shown in FIGS. 42A and 42B. The needle guard 22 a ofFIG. 42C includes an integrally molded needle trap 41 a, a notch 61 a, arecess 61 b in trap 41 a, and needle guard 22, respectively. A resilientmember 102 is held within notch 61 a and recess 61 b. The stored energyof resilient member 102 urges needle trap 41 a toward or against needle10. Resilient member 102 may comprise a “v” shape or may simply comprisea member that has been curved to create a stored energy.

FIG. 43A is a full side view one embodiment of the present inventionwith the resilient member 119 extended and still exerting force on theneedle guard assembly 22, said resilient member 119 assists inherentlymolded bias of needle guard trap 41 by urging said needle guard trap 41inwardly and in front of the sharpened needle tip 11 (see FIG. 33), saidneedle guard assembly 22 is limited from advancing further by thelimiting tether 24, with the sharpened hypodermic needle tip beingentrapped within the needle guard assembly 22, with the needle guardtrap 41 now securely positioned in front of the sharpened needle tip 11said needle guard trap 41 blocking the aperture guide opening 47 of theneedle guard assembly 22, ensuring safe containment of said sharpenedtip 11 within the needle guard assembly 22. The needle guard trap 41 isattached to the needle guard assembly 22 by a hinge section 40. A hollowbore hypodermic needle 10 is fixedly attached to a hub 112, said hub 112having at least one proximal flange 101 for attaching said hub 112 to amale luer fitting, said hub 112 also having a flange 16 for removablyattaching a protective storage cover (not shown), said flange 16 havingat least one shoulder or projection 14 for interfacing with acorresponding portion of a storage cover to allow twisted attachmentand/or removal of said hub 112 to or from a medical device, said hubalso having a body portion 15, a protrusion 5, and a movable latchingarm 26, said latching arm 26 being fixedly attached to said hub body 15by a hinge section 23, said latching arm also having a hook 21, aprotrusion, cam, or ramp 49 and a finger pad or button 27.

FIG. 43B shows the protective needle guard assembly of FIG. 43A attachedto a syringe 6. The protective needle guard assembly may be integral tosyringe 6, or may be attached as an add-on component.

FIG. 44A is a full side view of the disclosed invention with theresilient member 119 extended and still exerting an extending force onthe needle guard assembly 22, said resilient member 119 assistsinherently molded bias of needle guard trap 41 by urging said needleguard trap 41 inwardly and in front of the sharpened needle tip 11 saidneedle guard assembly 22 is limited from advancing further by thelimiting tether 24, with the sharpened hypodermic needle tip 11 beingtrapped within the needle guard assembly 22, with the needle guard trap41 now securely positioned in front of the sharpened needle tip 11. Saidneedle guard 22 having an extended slot section 44 a for releasablyholding said needle guard assembly 22 in a retained position. Saidextended slot section 44 a places the interface between the latching armhook 21 and the needle guard assembly 22 away from any potential bindingwhich may occur during needle insertion. If the retaining meansinterface is too close to the insertion surface, the latching arm 26 maybe prevented from releasably holding the needle guard assembly 22. Aflexible projection 107 is included within the needle guard assembly forretaining the end coil of spring 119 in a locked position after theneedle tip protection device has been activated. FIG. 44B illustrates across-sectional view of flexible projection 107. The needle guard trap41 is attached to the needle guard assembly 22 at a hinge section 40.The needle 10 is fixedly attached to a hub 112, said hub 112 having atleast one proximal flange 101 for attaching said hub 112 to a male luerfitting, said hub also having a body portion 15, a protrusion 5, and amovable latching arm 26, said latching arm 26 being fixedly attached tosaid hub body 15 by a hinge section 23, said latching arm also having ahook 21 and protrusion 49.

FIG. 45A is a full side view drawing of the needle hub 412, inaccordance with one embodiment of the invention comprising a hypodermicneedle hub 412 with a flange 401 for attaching the needle hub 412 to amale luer fitting, a needle nest 404 for fixedly attaching the needle, aplurality of fins 402, and a land 75 for attaching another component tothe hub 412.

FIG. 45B is a full top view of the needle hub 412 shown in FIG. 45Bhaving a flange 401 for attaching the needle hub 412 to a male luerfitting, a needle nest 404 for fixedly attaching a needle, a pluralityof fins 402, and a land 75 for attaching another component to the hub412.

FIG. 45C is a cross sectional side view of FIG. 45A comprising ahypodermic needle hub 412 with a flange 401 for attaching the needle hub412 to a male luer fitting a needle nest 404 for fixedly attaching theneedle 10, an aperture therethrough creating a fluid/gaseous path fromthe said hub 412 to said needle 10, a plurality of fins 402, and a land75 for attaching another component to the hub 412.

FIG. 46 is a full side view drawing of the disclosed inventioncomprising a hypodermic needle hub 412 with a flange 401 for attachingthe needle hub 412 to a male luer fitting, a needle nest 404 for fixedlyattaching the needle, at least one, or a plurality of shortened fins403, and a land 75 for attaching another component to the hub 412.

FIG. 47 is a full front view drawing of FIGS. 45A and 46 comprising ahypodermic needle hub 412 with an aperture creating a fluid/gaseous pathto the hypodermic needle 10, a needle nest 404 having adjacent at leastone, or a plurality of fins 402 or 403, at least one, or a plurality offlanges 401 and a land 75.

FIG. 48A is a is a full side view of the invention having a retrofittedhub portion 215 being fixedly attached to a hub portion 412 by aheatstake connection. Said hub portion 215 having an annular flange 16for connecting a protective storage cover, a protrusion 17 for attachinga tether, said protrusion 17 having an aperture for insertably attachingor bonding the tether, said protrusion 17 having an angled proximal endto eliminate any possibility of the tether catching on the protrusion 17when the needle guard 22 is activated. A hub portion 215 also includes awell or pocket 18 for removably inserting a tether in an out of the wayfashion, and a retaining means 77 for releasably holding said needleguard 22 in a retained position adjacent to said hub portion 215.

FIG. 48B is a full front view of the hub 215 described in FIG. 48Acomprising a hypodermic needle hub 215 having an aperture with aplurality of slots which correspondingly fits onto the distal end of ahypodermic needle hub shown throughout this application, said slotsaccept the fin or fins 402 from said hub 412, an annular flange 16, aprotrusion 17 for attaching a tether or the like, a well or pocket 18for removably inserting a tether or the like, and a retaining means 77having an aperture 78 for releasably holding said needle guard 22 in aretained position adjacent to said hub portion 215.

FIG. 48C is a full front view of FIG. 48A comprising a hypodermic needlehub portion 215, an aperture which correspondingly fits onto the distalend of a hypodermic needle hub shown throughout this application, anannular flange 16. There is one slot shown with the aperture, and atleast one slot is needed to secure the needle hub 412 and hub portion215 together to keep the hub portion 215 and needle hub 412 aligned whena circumferential force is exerted on the adjacent components.

FIG. 49A is a full side view of the disclosed invention being fixedlyattached to a prior art needle hub 12 having at least one flange 1 forattaching the needle hub 12 to a male luer fitting, a section 16 forremovably holding a protective storage cover 54 over the hypodermicneedle 10 (shown in other drawings in this application), a protrusion 5located at the distal end of the hub portion 15, said protrusion 5 beingconnected to the hub portion 15 at the distal end of the hub portion 15,said section 16 having a shoulder 14 for twistedly attaching saidinvention to said storage cover, and a moveable latching arm 26 with afinger pad 27, attached to the hub portion 15 by a hinge section 23,said finger pad 27 having at least one protrusion for creating a morepositive grip or contact with said finger pad 27. Finger pad 27 alsocomprising a different, or bright color, which serves as a visualindicator for the user to easily locate the finger pad for manualrelease of said needle guard assembly 22 or the like, with the moveablelatching arm 26 having a protrusion 21 for retaining a component in areleasable position adjacent to said hub portion 15, said moveablelatching arm 26 shown in the preferred molded position.

FIG. 49B is a cross-sectional side view of FIG. 49A showing thedisclosed invention attached to a prior art needle hub 12 said needlehub 12 comprising a hypodermic at least one flange 1 for attaching theneedle hub 12 to a male luer fitting, on one side a needle nest 4 forfixedly attaching the needle (not shown) said needle nest 4 having atleast one, or a plurality of fins 2 and an inner aperture creating afluid/gaseous path between the needle hub 12 and the needle. Theinvention is shown being retrofitted to said prior art hub 12, saidattachment means comprising a spin weld, sonic weld, heat weld, ormechanical attachment means as shown by the protrusion 64 being attachedby means of a snap fit or friction fit, said needle nest 4 having arecess or slot manufactured to accept said protrusion 64 of hub portion15, said hub portion 15 having a protrusion 5 located at the distal endof the hub portion 15, said protrusion 5 being connected at the distalend of the hub portion 15, said hub portion 15 also having a section 16for removably attaching a protective storage covers (not shown) saidsection 16 also having a means for creating a tortuous path preventingcontamination from entering the sterile field created by enclosing theneedle 10, needle guard 22 and hub portion 15 within a protectivestorage cover. Hub portion 15 includes a moveable latching arm or lever26 attached to the hub portion 15 by a hinge section 23, with themoveable latching arm 26 having finger pad or button 27, a protrusion 21for retaining a component in a releasably held position adjacent to thehub portion 15, said latching arm 26 also having a protrusion 49 forbiasing the latching arm 26 in an outward manner when a compressiveforce is applied to the releasably held needle guard 22 with saidmoveable latching arm 26 shown in the preferred position for retainingat least one component in a retained position on the hypodermic needlehub 12.

FIG. 50 is a cross-sectional side view of the invention attached to aprior art glass pre-filled syringe 6 having a nest bead 7 and ahypodermic needle 10 showing the disclosed invention attached to saidglass pre-filled syringe 6. Hub body 15 is fixedly attached to syringe 6at the nest bead 7 by the attaching section 65; said hub body 15 havinga protrusion 5 located at the distal end of said hub portion 15, saidprotrusion 5 being connected at the distal end of the hub portion 15,said hub portion 15 having a fixedly attached tether 24, said hub body15 also having a section 16 for removably attaching a protective storagecover a moveable latching arm or lever 26 attached to the hub body 15 bya hinge section 23, said lever 26 having a touch pad 27, a protrusion 21for retaining a component in a releasable position on the hub portion15, said latching arm 26 also having a protrusion 49 for urging saidlatching arm 26 in an outward manner when a compressive force is appliedto a releasably held needle guard with said moveable latching arm 26shown in the preferred position for retaining at least one component ina retained position on the hub portion 15.

FIG. 51 is a cross-sectional side view of the invention attached to aprior art pre-filled cartridge syringe hub 8 a having a fixedly attachedneedle 10 with a sharpened proximal end 111 and a sharpened distal end,said sharpened proximal end 111 for piercing the stopper of a medicineor fluid cartridge. Hub portion 15 is fixedly attached to said syringehub 8 a at the needle nest 4 said hub portion 15 having a protrusion 5located on said hub portion 15, said protrusion 5 having an attachmentsection 17 with an aperture for inserting a tether (not shown), saidattachment section 17 having an chamfered face on the proximal side toeliminate any possibility of the tether catching and hanging up on saidattachment section 17 when said needle guard is released from a retainedposition, said hub portion 15 also having a section 16 for removablyattaching a protective storage cover and a moveable latching arm orlever 26 with a touch pad 27 attached to the hub portion 15 by a hingesection 23, with the moveable latching arm 26 having a protrusion 21 forretaining a component in a releasably held position on the hub portion15, said latching arm 26 also having a protrusion 49 for urging thelatching arm 26 in an outward manner when a compressive force is appliedto a releasably held needle guard with said moveable latching arm 26shown in the preferred position for retaining at least one component ina retained position on the hub body 15.

FIG. 52 is a cross-sectional side view of the invention integrallymolded to a pre-filled cartridge syringe hub 8 b having a fixedlyattached needle 10 with a sharpened proximal end 111 and a sharpeneddistal end (not shown) said sharpened proximal end 111 is for piercingthe stopper of a medicine or fluid cartridge. Integral hub portion 15having a needle nest 4, protrusion 5 located on said hub portion 15,said protrusion 5 having an attachment section 17 with an slot forinserting a tether (not shown) said attachment section 17 having anchamfered face on the proximal side to eliminate any possibility of thetether 24 catching and hanging up on said attachment section 17, saidhub portion 15 also having a section 16 for removably attaching aprotective storage cover, a moveable latching arm or lever 26 attachedto the hub portion 15 by a hinge section 23, with the moveable latchingarm 26 having a protrusion 21 for retaining a component in a releasableposition adjacent to the hub portion 15, said latching arm 26 alsohaving a protrusion 49 for urging the latching arm 26 in an outwardmanner when a compressive force is applied to a releasably held needleguard 22 (shown in other drawings in this application), with saidmoveable latching arm 26 shown in the preferred position for retainingat least one component in a retained position on the hub portion 15.

FIG. 53 is a cross-sectional side view drawing of a prior art indwellingintravenous (I.V.) catheter 29 having a catheter mounting section 9 witha section 18 for removably attaching a protective storage cover, afixedly attached hypodermic needle 10, and a male section 78 forremovably attaching an indwelling I.V. catheter hub 13.

FIG. 54 is a cross-sectional side view an I.V. catheter having amounting section 9, a section 18 for removably attaching a protectivestorage cover a hypodermic needle 10 being fixedly attached to a needlenest 4; said catheter mounting section 9 being retrofitted with thepresent invention. The invention comprises a hub portion 15 beingfixedly attached to said catheter mounting section 9 at the nest 4 bythe attaching section 66, said hub portion 15 having a protrusion 5located at the distal end of said hub portion 15, said protrusion 5being connected to the hub portion 15, said hub portion 15 having afixedly attached tether 24, said hub portion 15 also having a section 16for removably attaching a protective storage cover, a moveable latchingarm or lever 26 attached to the hub portion 15 by a hinge section 23,with the moveable latching arm 26 having a protrusion 21 for retaining acomponent in a releasable position on the hub portion 15, said latchingarm 26 also having a protrusion 49 for urging the latching arm 26 in anoutward manner when a compressive force is applied to the releasablyheld needle guard (not shown), with said moveable latching arm 26 shownin the preferred position for retaining at least one component in aretained position on the hub portion 15.

FIG. 55 is a cross-sectional side view of the present inventionintegrally molded to an I.V. catheter mounting section 9.

FIG. 56 illustrates a hub portion 15 of the present invention that maybe attached to a blood collection device similar to that showing FIG.25.

FIG. 57 is a full front view of the needle guard assembly 22 of FIG. 11further comprising at least one fin 63 protecting the movement of saidlatching arm 26, allowing said latching arm 26 to freely disengage whenthe needle guard 22 is moved towards the hub 12 when said needle guard22 contacts the protrusion 49.

FIG. 58. is a cross-sectional side view of a prior art pre-filledsyringe cartridge comprising a glass cartridge 6, a glass cartridge hub68 having a needle nest 4 for fixedly attaching a needle 10, said needle10 having a sharpened distal end 11 said hub 68 also having a threadedsection 67.

FIG. 59 is a cross sectional side view of the invention being threadedlyattached to a glass cartridge hub 68, said glass cartridge 25 hub 68being fixedly attached to a glass cartridge 6, said hub 68 having aneedle nest 4 for fixedly attaching a needle 10, said needle 10 having asharpened distal end (not shown) said hub 68 also having a threadedsection 67. Hub body 15 is fixedly attached to said glass cartridge hub68 by the threaded section 67, said hub 15 having a protrusion 5 locatedat the distal end of said hub portion 15, said protrusion 5 beingconnected at the distal end of the hub portion 15, said hub portion 15having a fixedly attached tether 24. Hub body 15 also includes a section16 for removably attaching a protective storage cover (FIGS. 78 and 79),a moveable latching arm or lever 26 with a touch pad 27 attached to thehub body 15 by a hinge section 23, with the moveable latching arm 26having a protrusion 21 for retaining a component in a releasableposition on the hub portion 15, said latching arm 26 also having aprotrusion 49 for urging said latching arm 26 in an outward manner whena compressive force is applied to a releasably held needle guard withsaid moveable latching arm 26 shown in the preferred position forretaining at least one component in a retained position on the hub body15.

FIG. 60 is a cross sectional side view of the invention being fixedlyattached to a glass cartridge 6, comprising a hub 69 having a needlenest 4 for fixedly attaching a needle 10, a hub portion 15 beingintegrally molded to said hub 69; said hub portion 15 having aprotrusion 5 located at the distal end of said hub portion 15, saidprotrusion 5 being connected at the distal end of the hub portion 15,said hub portion 15 having a fixedly attached tether 24, said tether 24could also be fixedly attached to section 16, said hub 69 also having asection 16 for removably attaching a protective storage cover, amoveable latching arm or lever 26 attached to the hub portion 15 by ahinge section 23, with the moveable latching arm 26 having a protrusion21 for retaining a component in a releasable position on the hub portion15, said latching arm 26 also having a protrusion 49 for urging saidlatching arm 26 in an outward manner when a compressive force is appliedto a releasably held needle guard 22, with said moveable latching arm 26shown in the preferred position for retaining at least one component ina retained position on hub 69.

FIG. 61 is a cross sectional top view of the invention shown on anindwelling catheter 29 embodiment, having a movable needle guard 22 aand a separable indwelling I.V. catheter 29, said catheter 29 beingfixedly attached to a catheter hub 13, an I.V. catheter mounting section9 having a fixedly attached hollow bore hypodermic needle 10 having asharpened distal end 11; a hub portion 15 having a section 16 forremovably attaching a protective storage cover 54, a slidable needleguard 22 a being fixedly attached to said hub portion 15 by means of alimiting tether, said needle guard 22 a having a projection or fingerpost 80 for advancing said separable catheter 29 and said needle guard22 a along said hypodermic needle 10 so said catheter may be insertedinto a blood vessel, said hypodermic needle 10 being slidable through aguide aperture 47 in said movable needle guard 22 a, said needle guard22 a having a movable needle trap 41 with a corresponding slot 31 forreceiving the needle trap 41 when said trap 41 moves beyond the needletip 11, said needle guard 22 a having an open collar or washer 30 forretaining the resilient member 19 on the proximal end of said needleguard 22 a, said resilient member 19 being slidably held on said needleguard 22 a by the notch or indentation 60, said movable needle trap 41having a lead-in area 33 for locating said resilient member 19 on saidneedle guard 22 a into notches 60 and/or 61, said needle trap 41 alsohaving a notch or indentation 61 for retaining said end coils of saidresilient member 19, with the distal end of said needle guard 22 ahaving a male section 78 for removably attaching an indwelling I.V.catheter hub 13, with a section of said male section 78 having a movablearm 42 for releasably retaining a catheter hub 13 from said male section78 during initial insertion of the catheter 29 into a patient. Saidcatheter hub 13 having an inner channel, recess, slot or undercut 32 forbeing releasably held by said movable arm 42. Said movable arm 42 couldalso comprise a metal component which is inserted during or after saidmale section 78 is manufactured.

Said hub portion 15 could also comprise the latching arm 26 shown inother drawings in this application, otherwise said needle guard 22 awould be releasably held adjacent to said hub portion 15 prior to use bya frictional or wedged means. FIG. 62 is a cross sectional top view ofthe movable needle guard 22 a shown in FIG. 61 on an indwelling catheterembodiment, containing the elements shown and described in the movableneedle guard 22 a, whereby the catheter 29 has been inserted in a bloodvessel and the needle 10 is being retracted into said needle guard 22 aas the needle 10 is being pulled away from said catheter insertion site,whereby the movable arm 42 on the male section 78 is free to move wherethe needle has been residing within the distal male section 78 of theneedle guard 22 a, allowing the catheter hub 13 to remain in the bloodvessel and freely separate from the needle guard 22 a, with the needletrap 41 sliding on said needle 10. The needle guard 22 a is attached tothe hub portion 15 shown in FIG. 61 whereby a fixedly attached tether(not shown) limits the forward movement of the needle guard 22 a, safelytrapping the needle tip 11.

Said catheter hub 13 having an inner channel, recess, slot or undercut32 for being releasably held by said movable arm 42.

FIG. 63 is a cross sectional top view of the movable needle guard 22 ashown in FIGS. 61 and 62 on an indwelling catheter 29 embodiment,containing the elements shown and described in FIGS. 61 and 62,including the movable needle guard 22 a, a tether (not shown) andcatheter 29, whereby the catheter 29 has been inserted in a blood vesseland the needle 10 is safely retracted within said needle guard 22 awhere by the movable arm 42 has moved inwardly releasing the hold on thecatheter hub 13, with the needle trap 41 now safely trapping the needletip 11. Movable arm 42 includes a corresponding receiving slot 166 forreceiving said movable arm 42. Said needle guard 22 a having saidmovable needle trap 41 located within the corresponding slot 31 aftersaid trap 41 has moved beyond the needle tip 11. Said needle guard 22 ais attached to the hub portion 15 as shown in FIGS. 61 and 62 whereby atether limits the forward movement of the needle guard 22 a, safelytrapping the needle tip 11. Said catheter hub 13 having an innerchannel, recess, slot or undercut 32 for being releasably held by saidmovable arm 42.

The movable arm protrusion 42 can comprise a “v” shaped configurationwhich allows the catheter hub 13 to separate even in the event themovable arm 42 has taken a set during storage. A set during storagecould inhibit the separation of said catheter hub 13 from said mountingsection 78.

FIG. 64 is a cross-sectional side view of the present invention readyfor use on a male luer syringe. FIG. 64 shows a full view of thehypodermic needle 10 comprising: a hub 12 with a fixedly attached needle10, a means for retaining a separate, movable needle guard 22, saidneedle guard 22 having an aperture therethrough for said hypodermicneedle 10, whereby the needle guard 22 is retained in a ready to useposition on said hub 12, with said retained needle guard 22 being urgedaway from said needle hub 12 by a compressed resilient member 19, saidresilient member 19 being located between, among or amid said hub 12 andsaid needle guard 22, said resilient member 19 also being located in anannular fashion surrounding a portion of said needle guard 22, saidneedle guard 22 is fixedly attached to said needle hub portion 15 bymeans of a limiting tether 24.

Said hub 12 having an aperture therethrough creating a fluid/gas path tosaid hypodermic needle 10, at least one flange 101 for attaching theneedle hub 12 to a male luer fitting, a needle nest 4 for fixedlyattaching the needle 10, said needle 10 having a sharpened distal end 11and an unsharpened proximal end being fixedly attached to said hub 12and an integral hub portion 15 having a protrusion 5 located at thedistal end of said hub body 15, said protrusion 5 being connected to thehub portion 15, said protrusion 5 having a fixedly attached tether 24,said hub portion 15 also having a section 16 for removably attaching aprotective storage cover, a moveable latching arm or lever 26 with atouch pad 27 attached to the hub portion 15 by a hinge section 23, withthe moveable latching arm 26 having a protrusion 21 for retaining acomponent in a releasably retained position on the hub portion 15, saidlatching arm 26 also having a protrusion 49 for biasing the latching arm26 in an outward manner when a compressive force is applied to thereleasably held needle guard 22; and a movable needle guard 22 having aproximal guide section 34, an internal guide section 35, with a recessor void 38 residing between said proximal guide section 34 and saidinternal guide section 35, a distal needle guide aperture 47, areceiving slot 31 to receive the needle trap 41 (not shown), a retainingarea 44 a with an aperture 48 to receive said protrusion 21, said needleguard 22 having a compressed resilient member 19 positioned at theproximal end of said needle guard 22 said with the resilient member 19exerting an extending force on said needle guard 22; with said needleguard 22 being releasable held in a compressed position by theprotrusion 21 of the moveable latching arm 26 on said hub portion 15, anaperture for orienting said needle guard assembly 22 adjacent to saidhub portion 12, said aperture having the hub protrusion 5 positionedtherethrough, said latching arm 26 having a protrusion 49 for engagingsaid needle guard assembly 22 when said needle guard 22 is urged towardsaid hub portion 12, said needle guard 22 engages protrusion 49 andmanually moves said latching arm 26 in an outward manner ensuring saidlatching arm 26 moves outwardly releasing the hold on the needle guardassembly 22.

FIG. 65 is a cross sectional top view of FIG. 64 containing the elementsshown and described in FIG. 64 with the releasably held needle guardassembly 22 being releasably held adjacent to said hub portion 15, saidguard assembly 22 being movable by the stored energy present in thecompressed resilient member 19, said resilient member 19 being slidablyretained on said needle guard 22 by the notch or indentation 60, saidmovable needle trap 41 having a lead-in area 33 for locating saidresilient member 19 on said needle guard 22 into notches 60 and/or 61,said needle trap 41 also having at least one notch or indentation 61 forreleasably retaining said end coils of said resilient member 19, saidneedle guard 22 having a proximal guide section 34, a distal needleguide aperture 47, a needle trap 41 biasly contacting said hypodermicneedle 10 by the inherent memory of the molded configuration of saidneedle trap 41 and/or the extending force of the surrounding resilientmember 19, whereby the advancing movement of said needle guard 22 islimited by a fixedly attached tether 24 (not shown), said needle 10having a sharpened distal end 11 and an unsharpened proximal end beingfixedly attached to said hub 12. Said needle trap 41 being hingedlyattached to said needle guard 22 by a hinge section 40, said needleguard 22 having a receiving slot 31 to receive the needle trap 41, adistal needle guide aperture 47.

FIG. 66 is a cross sectional top view of FIGS. 64 and 65 containing theelements described in FIGS. 64 and 65 with the releasably held needleguard assembly 22 being urged toward the distal end of the hypodermicneedle 10 by the extending force of the resilient member 19, having aneedle trap 41 biasly contacting said hypodermic needle 10 by theinherent memory of the molded configuration of said needle tip guard 41and/or the extending force of the surrounding resilient member 19,whereby the advancing movement of said needle guard 22 is limited by afixedly attached tether (not shown). Said resilient member 19 beingslidably retained on said needle guard 22 by the notch or indentation60, said movable needle trap 41 having a lead-in area 33 for locatingsaid resilient member 19 on said needle guard 22 into notches 60 and/or61, said needle trap 41 also having at least one notch or indentation 61for releasably retaining said end coils of said resilient member 19.Said needle trap 41 being hingedly attached to said needle guard 22 by ahinge section 40, said needle guard 22 having an integral metal guard 75and a distal needle guide aperture 47. Said needle guard 41 also havinga tapered or reducing proximal section 304 for non-binding access by themovable resilient member 19. Said resilient member 19 being movablypositioned in an annular manner about or around the proximal section ofsaid needle guard 22.

FIG. 67 is a cross sectional top view FIGS. 64, 65 and 66 showing theneedle tip 11 being trapped within the needle guard 22 by the movableneedle guard 41, comprising a hypodermic needle 10 having a sharpenedtip 11, said needle guard 22 being movably attached to said hub portionby means of a limiting tether (not shown), with the resilient member 19extended and maintaining an extending force on the needle guard assembly22, said needle guard is prevented from advancing further by thelimiting feature of said limiting tether, said needle guard 22 havingonly one notch 60 for maintaining an extending force of said resilientmember 19 on said needle guard 22, said needle guard 22 maintainingalignment on said hypodermic needle 10 by means of the guide sectionsshown throughout this application. Said proximal guide 34 is shown heremaintaining the needle guard 22 in a substantially concentric manner onsaid hypodermic needle 10. Said needle guard 41 also having a tapered orreducing proximal section 304 for non-binding access by the movableresilient member 19.

FIG. 68 is a full side view of the invention without the needle 10,comprising a hub 12 that is attachable to a male luer fitting, said hub12 having at least one flange 101 at the proximal end a hub portion 15,said hub portion 15 having a protrusion 5, a protrusion 17 having anaperture for attaching a tether 24, a movable latching arm 26 having ahook 21 and a protrusion 49, said latching arm 26 being hingedlyattached to said hub portion 15 by a hinge 23, with said tether 24 beingfixedly attached to a movable needle guard 22, said needle guard 22having a movable needle trap 41 being hingedly attached to said needleguard 22 by the hinge 40, said needle trap 41 having at least one notchor multi-level landing 61 for proper positioning of a resilient member19 (not shown), said needle trap 41 having a lead in section 33 also forlocating said resilient member 19 in a compressed and/or extendibleposition, said needle guard 22 having a protrusion 44 a for maintaininga releasable hold on said needle guard 22 when said needle guard 22 isretained adjacent to said hub portion 15 by said latching arm 26 andhook 21, said needle trap having a different, or brightly coloredindicator 64 which is visible only when the resilient member is retainedin a compressed positioned on said needle guard 22 before the needleguard 22 is activated. The resilient member covers said indicator 64shielding said indicator 64 from view when the needle guard 22 isactivated and said resilient member 19 is extended around said needleguard 22 and the movable needle trap 41. Said resilient member 19maintains said needle trap 41 in a protective position on said needleguard 22. Said indicator 64 could easily be located anywhere on saidneedle guard 22 where the advancing resilient member 19 hides theindicator 64 from view alerting the user that the device is safelyshielding the sharpened needle tip 11 thus preventing an unintentionalpercutaneous needlestick injury.

FIG. 69 is a full, outside, top view of the needle guard assembly 22shown in its molded configuration comprising a foldable, open-facedneedle guard 22 having a hinge section 28, with adjacent lands 39 whichcreate an aperture when said needle guard assembly 22 is coupledtogether, a front section 62, at least one fin 63 for allowing adequateclearance for a latching arm to freely be urged from a releasablyholding position on said needle guard 22 when the invention is activatedduring use. A slot or void 25 is created when the needle guard 22sections are joined together. A retaining protrusion 44 b is locatedadjacent to said slot 25, said retaining protrusion 44 b interfaces withthe hook of a latching arm (not shown), a notch 60 for positioning andmaintaining the extending force of a resilient member on said needleguard 22 when said guard 22 is in a retained and extending mode, atapered or reduced proximal end 45 for eliminating any binding effectcaused when the resilient member moves around or about the proximal endof said needle guard 22, said needle guard 22 having a movable needletrap 41 being hingedly attached to said needle guard by the hinge 40,said needle trap 41 having at least one notch or multi-level landing 61for proper positioning of a resilient member said needle trap 41 havinga lead in section 33 also for locating said resilient member in acompressed and/or extendible position. Said needle trap 22 being fixedlyattached to a tether 24, said tether having at least one protrusion 20for fixedly attaching said tether 24 to said hub portion 15 or hub 12,or flange 16.

FIG. 70 is a view of the proximal end of the tether 24 having aplurality of protrusions 20 a for fixedly attaching said tether 24 tosaid hub portion 15 or hub 12, or flange 16.

FIG. 71 is a is a full, inside face view of the needle guard assembly 22shown in its molded configuration comprising a foldable, open-facedneedle guard 22 having a hinge section 28, with adjacent lands 39 whichcreate an aperture when said needle guard assembly 22 is coupledtogether, a slot or void 25 is created when the needle guard 22 sectionsare joined together, a distal guide section 47 is also created when theneedle guard 22 sections are joined together, a retaining protrusionramp 44 c is located adjacent to said slot 25, said retaining protrusioninterfaces with the hook 21 of the latching arm 26 (both shown in otherdrawings in this application), said needle guard 22 having a movableneedle trap 41 being hingedly attached to said needle guard by the hinge40, said needle trap 41 having at least one skirt or fin 46 forentrapping said sharpened needle tip 11 (see FIG. 75), said needle guardhaving a corresponding slot or opening 31 for receiving said needle trap41, said needle guard 22 having at least one pin 36 and a correspondingopening 37 for frictionally engaging said needle guard 22 sectionstogether about a hypodermic needle, said pin 36 and slot 37 can bepositioned on either side of needle guard 22 sections, said needle guard22 having an internal guide section 35 and a proximal guide section 34with a void or space 38 between said guides 34 and 35, said needle traphaving an internal landing 52 located between said internal guide 35,with said landing 52 having an adjacent landing 53 which serves to guidethe hypodermic needle during assembly, storage and use, said landing 53also houses said sharpened needle tip within said needle guard 22. Saidneedle guard 22 being fixedly attached to a tether 24. Said tether 24having at least one protrusion 20 for fixedly attaching said tether 24to said hub portion 15 or hub 12, or flange 16.

FIG. 72 is a full front view of the needle guard assembly 22 shown in anopen-faced configuration comprising a needle guard assembly 22 having aninternal guide section 35, a hinge section 28 with a plurality of needleguard 22 sections connected adjacent to said hinge section 28, saidhinge section 28 having an adequate area for insert molding a separatetether or fixedly attaching a separate tether, said hinge section 28also could have an aperture therethrough for fixedly inserting aseparate tether, said needle guard 22 having a split line 43 where theneedle guard 22 sections mate or join together, an aperture guide 47 oneach section at the distal end, a recess 25 on one section having aprotrusion 98 a for joining with the corresponding element 98 b on theother section of said needle guard assembly 22, and a post 36 forjoining the needle, guard assembly 22 sections together. Said post 36 isreceived by a corresponding slot or opening 37 (shown as a dotted line).

FIG. 73 is a full rear view of the needle guard assembly 22 shown in anopen-faced configuration comprising a needle guard assembly 22 having ahinge section 28 joining each section, said hinge section 28 having aslot or recess for inserting a fixedly attached, separate tether (notshown), said hinge section 28 also having a fin 79 being hingedlyattached to said hinge section 28, said fin 79 being bendable over saidhinge section 28 for fixedly attaching a separate tether by a heat weldor press means, said needle guard 22 having a split line 43 where theneedle guard 22 sections mate or join together, an aperture guide 34 oneach needle guard 22 section, a protrusion 98 b for joining with thecorresponding element 98 b on the alternate needle guard assembly 22section, a moveable needle trap 41, at least one post or protrusion 36on one needle guard assembly 22 section which enters at least onecorresponding slot 37 on the other needle guard assembly 22 section forsecuring the sections together. Said post 36 is received by acorresponding slot or opening 37 (shown as a dotted line).

FIG. 74 is a full, inside face view of one half of the needle guardassembly 22 containing the elements shown and described in FIG. 71showing said needle guard 22 in its molded configuration comprising afoldable, open-faced needle guard 22 having a hinge section 28 forattaching a separate tether with adjacent lands 39 which create anaperture when said needle guard assembly 22 is coupled together, a slotor void 25 is created when the needle guard 22 sections are joinedtogether, a distal guide section 47 is also created when the needleguard 22 sections are joined together, said needle guard 22 having acorresponding slot or opening 31 for receiving said needle trap 41 (seeFIG. 71), said needle trap having at least one pin 36 (see FIG. 71) anda corresponding opening 37 for frictionally engaging said needle guard22 sections together about the hypodermic needle, said pin 36 and slot37 (see FIG. 71) can be positioned on either side of needle guard 22sections, said needle guard 22 having an internal guide section 35 and aproximal guide section 34 with a void or space 38 between said guides 34and 35, said needle trap having an internal landing 52 located betweensaid internal guide 35, with said landing 52 having an adjacent landing53 which serves to guide said hypodermic needle during assembly, storageand use, said landing 53 also houses said sharpened needle tip withinsaid needle guard 22. Said needle guard 22 being fixedly attached to aseparate tether (not shown) at hinge section 28.

FIG. 75 is a cross sectional view of the needle guard 22 in FIG. 71shown in axis 75-75 comprising a needle guard 22, a movable needle trap41 and fins or skirts 46. Said skirts 46 maintain alignment of thetrapped sharpened needle tip within said needle trap 41.

FIG. 76 is a cross sectional view of the needle guard 22 in FIG. 71shown in axis 76-76 comprising a needle guard 22, a split line 43, aslot 37 and a landing 53.

FIG. 77 is a cross sectional view of the needle guard 22 in FIG. 74shown in axis 77-77 comprising a needle guard 22, a split line 43, aguide section 35, said guide section 35 having chamfered or angled endsfor aligning a hypodermic needle within said guide section 35 on saidneedle guard 22 during the assembly procedure, said hypodermic needle 10(shown in other drawings in this application) resides adjacent to thelanding 52.

FIG. 78 is a cross sectional side view of a hypodermic needle for use ona male luer syringe in a ready for use state in accordance with oneembodiment of the present invention. The needle assembly is containedwithin a protective storage cover 54 and end cap 68, whereby needle 10,needle guard 22, resilient member 19, tether 24, hub 12 and flange 16are held within said cover 54 by a wedging action of said flange 16 withthe cover 54. FIG. 78 further illustrates a hub 12, a fixedly attachedneedle 10, a means for retaining a separate, movable needle guard 22,said needle guard 22 having an aperture therethrough for said hypodermicneedle 10, whereby the needle guard 22 is retained in a ready to useposition on said hub 12, with said retained needle guard 22 being urgedaway from said needle hub 12 by a compressed resilient member 19, saidresilient member 19 being located between, among or amid said hub 12 andsaid needle guard 22, said resilient member 19 also being located in anannular fashion about or surrounding a portion of said needle guard 22,said needle guard 22 is fixedly attached to said needle hub portion 15by means of a limiting tether 24.

Said hub 12 having an aperture therethrough creating a fluid/gas path tosaid hypodermic needle 10, at least one flange 101 for attaching theneedle hub 12 to a male luer fitting, a needle nest 4 for fixedlyattaching the needle 10, said needle 10 having a sharpened distal end 11and an unsharpened proximal end being fixedly attached to said needlenest 4, and an integral hub portion 15 having a protrusion 5 located atthe distal end of said hub portion 15, said protrusion 5 being connectedto the hub portion 15, said hub portion 15 having a fixedly attachedtether 24, said hub portion 15 also having a section 16 for removablyattaching said protective storage cover 54, a moveable latching arm orlever 26 with a touch pad 27 attached to the hub portion 15 by a hingesection 23, with the moveable latching arm 26 having a protrusion 21 forretaining a component in a releasably held position adjacent or on saidhub portion 15, said latching arm 26 also having a protrusion 49 forbiasing the latching arm 26 in an outward manner when a compressiveforce is applied to said releasably held needle guard 22, said movableneedle guard 22 having a proximal guide section 34, an internal guidesection 35, with a recess or void 38 residing between said proximalguide section 34 and said internal guide section 35, a distal needleguard guide aperture 47, a receiving slot 31 to receive the needle trap41 (not shown) a retaining area 44 a with an aperture 48 to receive saidprotrusion 21, said needle guard 22 having a compressed resilient member19 positioned at the proximal end of said needle guard 22 said with theresilient member 19 exerting an extending force on said needle guard 22;with said needle guard 22 being releasable held in a compressed positionby the hook 21 of the moveable latching arm 26 on said hub portion 15,an aperture for orienting said needle guard assembly 22 adjacent to saidhub portion 12, said aperture having the hub protrusion 5 positionedtherethrough, said latching arm 26 having a protrusion 49 for engagingsaid needle guard assembly 22 when said needle guard 22 is urged towardsaid hub portion 12, said needle guard 22 engages protrusion 49 andmechanically urges said latching arm 26 in an outward manner ensuringsaid latching arm 26 moves outwardly releasing the hold on the needleguard assembly 22.

Said cover 54 having at least one internal projection 56, saidprojection holding said needle guard 22 and resilient member 19 in aretracted state during storage and prior to use, said cover 54 having aprojection 55 for biasly holding or wedging said latching arm 26 in aretaining manner, said latching arm 26 releasably holding said needleguard 22 and said resilient member 19 in a retained position prior touse. The diameter of said cover 54 could also be sized to biasly holdsaid latching arm 26 in a retaining manner, therefore, eliminating theneed for said projection 55.

A cap 68 is removably placed into or on said cover 54 to contain saidneedle assembly within said cover 54 and said cap 68, said cap 68 havinga plurality of square shoulders 69, and a wall section 70 removablysealing said cover 54 and said cap 68 together at the tortuous pathinterface 71 maintaining a sterile field within said cover 54 and cap68. Said projection 56 relieves the extending force of said resilientmember 19 on said releasably held needle guard 22, said retaininglatching arm 26 and said hinge 23 of said latching arm 26, by slightlycompressing said resilient member 19, while said projection 55 holdssaid latching arm 26 in a wedged or confined position whereby saidneedle guard 22 is releasably held by said latching arm 26 when saidcover 54 is removed from said needle assembly.

FIG. 79 is a cross sectional side view of the invention comprising ahypodermic needle for use on a pre-filled syringe or pre-filledcartridge syringe in a ready for use state having a needle guard 22 andhypodermic needle 10 being stored and retained in a protective storagecover 54, showing a full view of said hypodermic needle 10, said cover54 having a means for retaining a separate, movable needle guard 22,said needle guard 22 having an aperture therethrough for said hypodermicneedle 10, said needle 10 having a distal sharpened end 11, whereby theneedle guard 22 is retained in a ready to use position, with saidretained needle guard 22 being urged away from said prefilled syringe bya compressed resilient member 19, said resilient member 19 being locatedbetween, among or amid said prefilled syringe and said needle guard 22,said resilient member also being located in an annular fashion about orsurrounding a portion of said needle guard 22, said needle guard 22 isfixedly attached to said needle hub portion 15 by means of a limitingtether 24.

Said integral hub portion 15 having a protrusion 5 located at the distalend of said hub portion 15, a moveable latching arm or lever 26 with atouch pad 27 attached to the hub portion 15 by a hinge section 23, withthe moveable latching arm 26 having a protrusion 21 for retaining acomponent in a releasably held position adjacent to or on said hubportion 15, said latching arm 26 also having a protrusion 49 for urgingsaid latching arm 26 in an outward manner when a compressive force isapplied to said releasably held needle guard 22, said movable needleguard 22 having a proximal guide section 34, an internal guide section35, a space or recess 38 between said proximal guide 34 and internalguide 35, a distal needle guard guide aperture 47, a receiving slot 31to receive a needle trap 41 (not shown), a retaining area 44 a with anaperture 48 to receive said protrusion 21, said needle guard 22 having acompressed resilient member 19 positioned at the proximal end of saidneedle guard 22 said with the resilient member 19 exerting an extendingforce on said needle guard 22; with said needle guard 22 beingreleasable held in a compressed position by the hook 21 of said moveablelatching arm 26 on said hub portion 15, an aperture for orienting saidneedle guard assembly 22 adjacent to said hub portion 12, said aperturehaving the hub protrusion 5 positioned therethrough, said latching arm26 having a protrusion 49 for engaging said needle guard assembly 22when said needle guard 22 is urged toward said pre-filled syringe, saidneedle guard 22 engages protrusion 49 and mechanically urges saidlatching arm 26 in an outward manner ensuring said latching arm 26 movesoutwardly releasing the hold on the needle guard assembly 22.

Said cover 54 having a soft elastomeric or rubber seal 72 inside orwithin the closed end of said cover 54 which sealingly engages saidsharpened tip 11 and said needle 10 of a pre-filled syringe orpre-filled cartridge against leakage.

FIG. 80 is a cross sectional view of the hub 12 contained within astorage cover 54 in axis 80-80 of FIG. 78 and comprising a hub section12, a storage cover 54 having at least one vane 57 for gripping a flangeshoulder of said hub 12 so the needle 10, said hub 12 and said needleguard 22 can be safely turned or twistedly attached with the cover 54 onor off a medical device.

FIG. 81 is a cross sectional view of the needle 10 contained within acover 54 in axis 81-81 of FIG. 79. Cover 54 includes at least one, or aplurality of internal projections 73, said projections 73 relieve theextending force of said resilient member 19 on said releasably heldneedle guard 22, said retaining latching arm 26 and said hinge 23 ofsaid latching arm 26, by slightly compressing said resilient member 19during storage.

FIG. 82 is a full front view of an open collar or washer 30 used withthe indwelling I.V. catheter embodiment of the invention, said washer 30retaining the resilient member 19 on the proximal end of the needleguard 22 a on said catheter assembly shown in FIGS. 62, 63, and 64. Saidwasher having an angled entrance 63 for engaging said washer onto saidneedle guard 22 a. Said washer 30 could comprise a flat configurationand be inserted into a corresponding slot on said needle guard 22 a tohold said resilient member 19 on said needle guard 22 a.

FIG. 83 is a cross sectional view of the washer 30 shown in along axis83-83 in FIG. 82.

FIG. 84 is a cross sectional top view of the invention containing theelements shown and described in FIG. 64 having a movable metal needletrap 41 used to trap the sharpened needle tip 11 within said needleguard 22, comprising a hub 12 at least one proximal flange 101, a hubportion 15 and a flange 16 for wedgedly and removably attaching aprotective cover, a releasably held needle guard assembly 22 beingreleasably held adjacent to said hub portion 15, said guard assembly 22being movable by the stored energy present in the compressed resilientmember 19, said resilient member 19 being slidably retained on saidneedle guard 22 by the notch or indentation 60, said metal needle trap41 having a lead-in area 33 for locating said resilient member 19 onsaid needle guard 22 into notches 60 and/or 61, said needle trap 41 alsohaving at least one notch or indentation 61 for releasably retainingsaid end coils of said resilient member 19, said needle guard 22 havinga proximal guide section 34, a distal needle guide aperture 47, a metalneedle trap 41 biasly contacting said hypodermic needle 10 by theinherent memory of the metal configuration of said needle trap 41 and/orthe extending force of the surrounding resilient member 19, whereby theadvancing movement of said needle guard 22 is limited by a fixedlyattached tether (not shown), said needle 10 having a sharpened distalend 11 and an unsharpened proximal end being fixedly attached to saidhub 12. Said needle trap 41 being hingedly inserted to said needle guard22 at a hinge slot 40, said needle guard 22 having a receiving slot 31to receive the needle trap 41, a distal needle guide aperture 47, saidneedle trap 41 having skirts 46 (shown in FIG. 75) to retain saidsharpened needle end 11 within said metal needle trap 41.

Said needle trap 41 being insertable onto said needle guard 22 from theoutside of said needle guard, allowing said needle trap 41 to beinserted onto said needle guard 22 either before or after said needleguard 22 is clasped around said hypodermic needle 10 from the sideduring assembly procedures.

FIG. 85 is a cross sectional top view of the invention containing theelements shown and described in FIGS. 64 and 84 having a movable metalneedle trap 41 used to trap the sharpened needle tip 11 within saidneedle guard 22, comprising a hub 12 at least one proximal flange 101, ahub portion 15 and a flange 16 for wedgedly and removably attaching aprotective cover, a releasably held needle guard assembly 22 beingreleasably held adjacent to said hub portion 15, said guard assembly 22being movable by the stored energy present in the compressed resilientmember 19, said resilient member 19 being slidably retained on saidneedle guard 22 by the notch or indentation 60, said metal needle trap41 having a lead-in area 33 for locating said resilient member 19 onsaid needle guard 22 into notches 60 and/or 61, said needle trap 41 alsohaving at least one notch or indentation 61 for releasably retainingsaid end coils of said resilient member 19, said needle guard 22 havinga proximal guide section 34, a distal needle guide aperture 47, a metalneedle trap 41 biasly contacting said hypodermic needle 10 by theinherent memory of the metal configuration of said needle trap 41 and/orthe extending force of the surrounding resilient member 19, whereby theadvancing movement of said needle guard 22 is limited by a fixedlyattached tether (not shown), said needle 10 having a sharpened distalend 11 and an unsharpened proximal end being fixedly attached to saidhub 12. Said needle trap 41 being hingedly inserted to said needle guard22 at a hinge slot 40 d, said needle guard 22 having a receiving slot 31to receive the needle trap 41, a distal needle guide aperture 47, areceiving slot 31 to receive the metal needle trap 41, said needle trap41 having skirts 46 (shown in FIG. 75) to retain said sharpened needleend 11 within said metal needle trap 41.

Said needle trap 41 being insertable onto said needle guard 22 from theinside of said needle guard, allowing said needle trap 41 to be insertedonto said needle guard 22 before said needle guard 22 is clasped aroundsaid hypodermic needle 10 from the side during assembly procedures.

FIG. 86 is a graph depicting the interaction of a resilient member and asliding member, said sliding member being on an elongated shaft, saidsliding member having a movable arm being urged away from said resilientmember by an extending force, said moveable arm being movably wedgedbetween the diameter of said resilient member and said shaft, said armslidably contacting said shaft, and where another area of said resilientmember is positioned around said sliding member, said resilient memberbeing releasably retained by said movable arm on said sliding member,said resilient member having a portion of said sliding member withinsaid resilient member's inside diameter, whereby the binding force ofsaid resilient member on said sliding member and said movable armeventually exceeds the extending force of said resilient member as saidresilient member extends. Said extending force of said resilient memberis greatest when said resilient member is completely compressed, andconversely, said extending force of said resilient member is weakestwhen said resilient member is completely elongated. The binding force ofsaid resilient member on said movable arm is greatest when saidresilient member is compressed.

FIG. 87 is a graph depicting the interaction of a resilient member and asliding member, said sliding member being on an elongated shaft, saidsliding member having a movable arm being urged away from said resilientmember by an extending force, said moveable arm being movably wedgedbetween the diameter of said resilient member and said shaft, said armslidably contacting said shaft, and where another area of said resilientmember is positioned in a notch or recess on said sliding member, saidresilient member being releasably retained by said movable arm and saidnotch on said sliding member, said resilient member having a portion ofsaid sliding member within said resilient member's inside diameter,whereby the binding force of said resilient member on said slidingmember and said movable arm is always less than the extending force ofsaid resilient member as said resilient member extends. Said extendingforce of said resilient member is exerted in the land created by saidnotch, maintaining a greater extending force on said sliding member andsaid movable arm than said binding force of said resilient member. Saidmovable arm is urged inwardly from a retaining position when saidsliding member advances beyond the end of said shaft, thereby releasingthe hold on said resilient member.

FIG. 88 is a cross-sectional side view of the present invention readyfor use on a male luer syringe showing a full view of the hypodermicneedle 10, and a cross sectional view of the releasing means shown anddescribed in FIG. 48A comprising a hub 412 with a fixedly attachedneedle 10, a means for retaining a separate, movable needle guard 22,said needle guard 22 having an aperture therethrough for said hypodermicneedle 10, whereby the needle guard 22 is retained in a ready to useposition on said hub 412, with said retained needle guard 22 being urgedaway from said needle hub 412 by a compressed resilient member 19, saidresilient member 19 being located between, among or amid said hub 412and said needle guard 22, said resilient member 19 also being located inan annular fashion surrounding a portion of said needle guard 22, saidneedle guard 22 is fixedly attached to said needle hub portion 215 bymeans of a limiting tether 24.

Said needle guard 22 having a retaining means 77, said retaining meanshaving an aperture 78 for releasably holding said needle guard 22 in aretained position adjacent to said hub portion 215, said needle guard 22having a latching arm 81 being hingedly attached to said needle guard 22at a hinge section 23, a protrusion 49 for urging said arm 81 from areleasably held position adjacent to said hub portion 215 when acompressive force is applied to said needle guard 22 and said protrusion49 engages said retaining means 77 and mechanically releases said holdon said needle guard 22, said arm 81 having a protrusion 21 forreleasably holding said arm 81 in said aperture 78 of said retainingmeans 77, said arm 81 having a finger pad 27 with projections which donot impede the movement of said pad 27 and said protrusion 21 throughsaid aperture 78 as said needle guard 22 is urged away from said hubportion 215.

Said hub 412 having an aperture therethrough creating a fluid/gas pathto said hypodermic needle 10, at least one flange 101 for attaching thehub 412 to a male luer fitting, a needle nest 4 for fixedly attachingthe needle 10, said needle 10 a sharpened distal end 11 and anunsharpened proximal end being fixedly attached to said hub 412 and anintegral hub portion 215 having a protrusion 5 located at the distal endof said hub portion 215, said protrusion 5 being connected to the hubportion 215, said protrusion 5 having a fixedly attached tether 24, saidhub portion 215 also having a section 16 for removably attaching aprotective storage cover said movable needle guard 22 having a proximalguide section 34, an internal guide section 35, with a recess or void 38residing between said proximal guide section 34 and said internal guidesection 35, a distal needle guide aperture 47, a receiving slot 31 toreceive the needle trap 41 said needle guard 22 having a compressedresilient member 19 positioned at the proximal end of said needle guard22 said with the resilient member 19 exerting an extending force on saidneedle guard 22; with said needle guard 22 being releasably held in acompressed position by the hook 21 of the moveable latching arm 81 onsaid needle guard 22, an aperture for orienting said needle guardassembly 22 adjacent to said hub portion 215, said aperture having thehub protrusion 5 positioned therethrough, said latching arm 81 having aprotrusion 49 for engaging said retaining means 77 when said needleguard 22 is urged toward said hub portion 215, said needle guard 22engages protrusion 49 and manually moves said latching arm 81 in anoutward manner ensuring said latching arm 81 moves inwardly releasingthe hold on the needle guard assembly 22.

FIGS. 89, 90 and 91 show a cross-section view of the invention describedin FIGS. 84, 85 and 88, respectively, wherein hub 212 includes athreaded section 74 for attaching the hub to a blood collection device.(See FIG. 25.)

FIGS. 92, 93 and 94 show a cross-section view of the invention describedin FIGS. 84, 85 and 88, respectively, being fixedly attached to aprefilled syringe.

FIG. 95 is a full side view drawing of the disclosed invention hubcomponent 12, comprising a hypodermic needle hub 12 with a flange 101for attaching the needle hub 12 to a male luer fitting, a needle nest 4,a section 16 for removably holding a protective storage cover over ahypodermic needle (not shown) a protrusion 5 located at the distal endof the hub portion 15, said hub portion 15 having at least one aperture89 for inserting a glue carrying fixture or the like to apply glue tothe needle during assembly, said aperture 89 also being a venting meansto allow pneumatic pressure to escape during insertion of needle 10 withglue into said needle nest 4, said protrusion 5 being connected to thehub portion 15 at the distal end of the hub portion 15, said section 16having a shoulder 14 for twistedly attaching said invention to a storagecover, and a moveable latching arm 26 with a finger pad 27, attached tothe hub portion 15 by a hinge section 23, said finger pad 27 having atleast one protrusion for creating a more positive grip or contact withsaid finger pad 27, said finger pad 27 also comprising a different, orbright color, which serves as a visual indicator for the user to easilylocate the finger pad 27 for manual release of a needle guard assemblyor the like, with the moveable latching arm 26 having a protrusion 21for retaining a component in a releasable position adjacent to said hubportion 15, said moveable latching arm 26 shown in the preferred moldedposition.

FIG. 96 is a full side view drawing of the disclosed invention hubcomponent 12, comprising a hypodermic needle hub 12 with a flange 101for attaching the needle hub 12 to a male luer fitting, a needle nest 4,a section 16 for removably holding a protective storage cover over thehypodermic needle (not shown), a protrusion 5 located at the distal endof the hub portion 15, said hub portion 15 having at least one aperture89 for inserting a glue carrying fixture or the like to apply glue tosaid needle 10 during assembly, said aperture 89 also being a vent toallow pneumatic pressure to escape during insertion of needle 10 intosaid needle nest 4, said protrusion 5 being connected to the hub portion15 at the distal end of the hub portion 15, said section 16 having ashoulder 14 for twistedly attaching said invention to a storage cover,and a moveable latching arm 26 attached to the hub portion 15 by a hingesection 23, with the moveable latching arm 26 having a protrusion 21 forretaining a component in a releasable position adjacent to said hubportion 15, said moveable latching arm 26 shown in the preferred moldedposition.

FIG. 97 is a cross-sectional side view of the invention attached to aprior art glass pre-filled syringe 6 having a nest bead 7 and ahypodermic needle 10 with a distal sharpened end 11, said needle 10having a change in profile 3 near the distal end for limiting axialmovement of a slidable needle guard 22 relative to the needle tip 11after positioning the needle guard at the distal end of the needle 10.FIG. 97 further shows a hub body 15 being fixedly attached to saidsyringe 6 at the nest bead 7 by the attaching section 65; said hub body15 having a protrusion 5 located at the distal end of said hub portion15, said protrusion 5 being connected at the distal end of the hubportion 15, said hub body 15 also having a section 16 for removablyattaching a protective storage cover, a moveable latching arm or lever26 attached to the hub body 15 by a hinge section 23, said lever 26having a touch pad 27, a protrusion 21 for retaining a component in areleasable position on the hub portion 15, said latching arm 26 alsohaving a protrusion 49 for urging said latching arm 26 in an outwardmanner when a compressive force is applied to the releasably held needleguard 22 (shown in other drawings in this application), with saidmoveable latching arm 26 shown in the preferred position for retainingat least one component in a retained position on the hub portion 15.

FIG. 98 is a cross-sectional side view of the invention integrallymolded to a pre-filled cartridge syringe hub 8 b having a fixedlyattached needle 10 with a sharpened proximal end 111 and a sharpeneddistal end 11, said needle 10 having a change in profile 3 near thedistal end for limiting axial movement of a slidable needle guardrelative to the needle tip 11 after positioning said needle guard at thedistal end of the needle 10, said sharpened proximal end 111 is forpiercing the stopper of a medicine or fluid cartridge. The inventionincludes an integral hub portion 15, having a needle nest 4; said hubportion 15 having a protrusion 5 located on said hub portion 15, saidhub portion 15 also having a section 16 for removably attaching aprotective storage cover, a moveable latching arm or lever 26 attachedto the hub portion 15 by a hinge section 23, with the moveable latchingarm 26 having a protrusion 21 for retaining a component in a releasableposition on the hub portion 15, said latching arm 26 also having aprotrusion 49 for urging the latching arm 26 in an outward manner when acompressive force is applied to the releasably held needle guard 22 withsaid moveable latching arm 26 shown in the preferred position forretaining at least one component in a retained position on the hubportion.

FIG. 99 is a cross-sectional side view of the invention attached to aprior art pre-filled cartridge syringe hub 8 a having a fixedly attachedneedle 10 with a sharpened proximal end 111 and a sharpened distal end11, said needle 10 having a change in profile 3 near the distal end forlimiting axial movement of a slidable needle guard (not shown) relativeto the needle tip 11 after positioning a needle guard at the distal endof the needle 10, said sharpened proximal end 111 for piercing thestopper of a medicine or fluid cartridge. The invention includes a hubportion 15 being fixedly attached to said syringe hub 8 a at the needlenest 4; said hub portion 15 having a protrusion 5 located on said hubportion 15, said hub portion 15 also having a section 16 for removablyattaching a protective storage cover, a moveable latching arm or lever26 with a touch pad 27 attached to the hub portion 15 by a hinge section23, with the moveable latching arm 26 having a protrusion 21 forretaining a component in a releasably held position on the hub portion15, said latching arm 26 also having a protrusion 49 for urging thelatching arm 26 in an outward manner when a compressive force is appliedto a releasably held needle guard, with said moveable latching arm 26shown in the preferred position for retaining at least one component ina retained position on the hub body 15.

FIG. 100A is a cross-sectional side view an I.V. catheter introducerhaving a hub section 9, having a fixedly attached needle 10 with asharpened distal end, said needle 10 having a change in profile 3 nearthe distal end for limiting axial movement of a slidable needle guard(not shown) relative to the needle tip 11 after positioning said needleguard 22 at the distal end of the needle 10, a section 18 for removablyattaching a protective storage cover, a hypodermic needle 10 beingfixedly attached to a needle nest 4; said catheter mounting section 9being retrofitted with the present invention, wherein hub portion 15 isfixedly attached to said catheter mounting section 9 at the nest 4 bythe attaching section 66, said hub portion 15 also having a section 16for removably attaching a protective storage cover.

FIG. 100B is a cross-sectional side view of the present inventionintegrally molded to an I.V. catheter introducer comprising a hub 9, ahypodermic needle 10 being fixedly attached to a needle nest 4 saidneedle 10 having a sharpened distal end 11, said needle 10 having achange in profile 3 near the distal end for limiting axial movement of aslidable needle guard (not shown) relative to the needle tip 11 afterpositioning said needle guard 22 at the distal end of the needle 10, ahub portion 15, said hub portion 15 having a protrusion 5 located onsaid hub portion 15, said hub body 15 also having a section 16 forremovably attaching a protective storage cover, a moveable latching armor lever 26 attached to the hub portion 15 by a hinge section 23, withthe moveable latching arm 26 having a protrusion 21 for retaining acomponent in a releasable position on the hub portion 15, said latchingarm 26 also having a protrusion 49 for urging said latching arm 26 in anoutward manner when a compressive force is applied to the releasablyheld needle guard with said moveable latching arm shown in the preferredposition for retaining at least one component in a retained position onthe hub portion 15.

FIG. 101 is a cross sectional side view of the invention beingthreadedly attached to a glass cartridge hub 68, said glass cartridgehub 68 being fixedly attached to a glass cartridge 6, said hub 68 havinga needle nest 4 for fixedly attaching a needle 10, said needle 10 havinga sharpened distal end 11, said needle 10 having a change in profile 3near the distal end for limiting axial movement of a slidable needleguard relative to the needle tip 11 after positioning said needle guard22 at the distal end of the needle 10, said hub 68 also having athreaded section 67 fixedly attaching hub body is to said glasscartridge hub 68 by the threaded section 67; said hub body 15 having aprotrusion 5 located at the distal end of said hub portion 15, saidprotrusion 5 being connected at the distal end of the hub portion 15,said hub body 15 also having a section 16 for removably attaching aprotective storage cover, a moveable latching arm or lever 26 with atouch pad 27 attached to the hub body 15 by a hinge section 23, with themoveable latching arm 26 having a protrusion 21 for retaining acomponent in a releasable position on the hub portion 15, said latchingarm 26 also having a protrusion 49 for urging said latching arm 26 in anoutward manner when a compressive force is applied to the releasablyheld needle guard 22 (shown in other drawings in this application), withsaid moveable latching arm 26 shown in the preferred position forretaining at least one component in a retained position on the hub body15.

FIG. 102 is a cross sectional side view of the invention being fixedlyattached to a glass cartridge 6, comprising a hub 68 having a needlenest 4 for fixedly attaching a needle 10, said needle 10 having asharpened distal end 11, said needle 10 having a change in profile 3near the distal end for limiting axial movement of a slidable needleguard relative to the needle tip 11 after positioning said needle guard22 at the distal end of the needle 10, a hub portion 15 being integrallymolded to said glass cartridge hub 69; said hub portion 15 having aprotrusion 5 located at the distal end of said hub portion 15, saidprotrusion 5 being connected at the distal end of the hub portion 15,said hub body 15 also having a section 16 for removably attaching aprotective storage cover, a moveable latching arm or lever 26 attachedto the hub portion 15 by a hinge section 23, with the moveable latchingarm 26 having a protrusion 21 for retaining a component in a releasableposition on the hub portion 15, said latching arm 26 also having aprotrusion 49 for urging said latching arm 26 in an outward manner whena compressive force is applied to the releasably held needle guard 22(shown in other drawings in this application), with said moveablelatching arm 26 shown in the preferred position for retaining at leastone component in a retained position on the hub body 15.

FIG. 103 is a cross sectional top view of the invention shown on anindwelling catheter 29 embodiment, having a movable needle guard 22 aand a separable indwelling I.V. catheter 29, said catheter 29 beingfixedly attached to a catheter hub 13; a hub 9 having a fixedly attachedhollow bore hypodermic needle 10 having a sharpened distal end 11, saidneedle 10 being fixedly attached to a hub portion 15 having a section 16for removably attaching a protective storage cover, a slidable needleguard 22 a being fixedly attached to said hub portion 15 by means of alimiting tether 24, said tether 24 being slidably disposed through anaperture on said hub 9, said needle guard 22 a having a projection orfinger post 80 for advancing said separable catheter 29 and said needleguard 22 a along said hypodermic needle 10 so said catheter 29 may beinserted into a blood vessel, said hypodermic needle 10 being slidablethrough a guide aperture in said movable needle guard 22 a, said needleguard 22 a having a movable needle trap 41 with a corresponding slot 31for receiving the needle trap 41 when said trap 41 moves beyond theneedle tip 11, said needle guard 22 a having an open collar or washer 30for retaining the resilient member 19 on the proximal end of said needleguard 22 a, said resilient member 19 being slidably held on said needleguard 22 a by the notch or indentation 60, said movable needle trap 41having a lead-in area 33 for locating said resilient member 19 on saidneedle guard 22 a into notches 60 and/or 61, said needle trap 41 alsohaving a notch or indentation 61 for retaining said end coils of saidresilient member 19, with the distal end of said needle guard 22 ahaving a male section 78 for removably attaching an indwelling I.V.catheter hub 13, said needle trap 41 having a movable arm 45 andprojection 42 for releasably retaining a catheter hub 13 from said malesection 78 after insertion of the catheter 29 into a patient. Saidcatheter hub 13 having at least one flange 301 and an inner channel,recess, slot or undercut 32 for being releasably held by said movablearm 42. Said movable arm 42 could also comprise a metal component whichis inserted during or after said male section 78 is manufactured. Saidchannel 32 can comprise an annular, or segmented configuration.

Said hub portion 15 could also comprise the latching arm 26 shown inother drawings in this application, otherwise said needle guard 22 awould be releasably held adjacent to said hub portion 15 prior to use bya frictional or wedged means. The disclosed invention is shown in aready to use state in FIG. 103.

FIG. 104 is a cross sectional top view of the invention shown showingthe catheter introducer needle tip 11 being withdrawn into the needleguard 22 a. The catheter 29 and catheter hub 13 remain releasably heldadjacent to said needle guard 22 a as the needle 10 is being withdrawnfrom the catheter insertion site through the distal guide 47 of saidneedle guard 22 a. This drawing shows said needle guard 22 a being heldwithin a housing or shroud 85. Said housing 85 having an inner chamberfor receiving a resilient member 19 and a slidable needle guard 22 a,said housing 85 also having exterior projections 86 serving as anon-slip gripping means, said projections 86 can be longitudinal, radialor the like, and may comprise any surface or contour which improves thehold by the user on said housing 85. Said housing 85 may also have aninternal projection 88 for fixedly attaching said needle guard 22 awithin said housing 85, and internal fins 97 to concentrically locatesaid resilient member 19 within said housing 85. Said needle guard 22 abeing held within said housing 85 by a snap-fit means created by thewedge 66 a and slot 66 b at the proximal end of said needle guard 22 a.Said housing 85 having a corresponding aperture to receive said wedge 66a and slot 66 b, said aperture having a “lead-in” 96 for easy assemblyof said guard 22 a into said housing 85. Said housing also may have aninternal ring or at least one projection 88 which correspondingly isreceived by a slot 89 in said needle guard 22 a. Said slot 89 andprojection 88 may be placed either on the guard 22 a or housing 85.

Said slidable needle guard 22 a being fixedly attached to a hub portionby means of a limiting tether 24, said hypodermic needle 10 beingslidable through a proximal guide aperture 34 in said movable needleguard 22 a, said needle guard 22 a having a movable needle trap 41 witha corresponding slot 31 for receiving the needle trap 41 when said trap41 moves beyond the needle tip 11, said needle guard 22 a having a notchor indentation 60 for releasably holding said resilient member 19 onsaid needle guard 22 a, said movable needle trap 41 having a lead-inarea 33 for locating said resilient member 19 on said needle guard 22 ainto notches 60 and/or 61, said needle trap 41 also having a notch orindentation 61 for retaining said end coils of said resilient member 19,with the distal end of said needle guard 22 a having a male section 78for removably attaching an indwelling I.V. catheter hub 13, said needletrap 41 having a movable arm 45 and projection 42 for releasablyretaining a catheter hub 13 from said male section 78 after insertion ofthe catheter 29 into a patient. Said catheter hub 13 having at least oneflange 301 and an inner channel, recess, slot or undercut 32 for beingreleasably held by said movable arm 45 and said projection 42. Saidmovable arm 45 could also comprise a metal component which is insertedduring or after said male section 78 is manufactured.

Said hub portion 15 could also comprise the latching arm 26 shown inother drawings in this application, otherwise said needle guard 22 awould be releasably held adjacent to said hub portion prior to use by africtional or wedged means.

FIG. 105 is a cross sectional and cut away top view of the movableneedle guard 22 a on an indwelling catheter 29 embodiment containing theelements shown and described in FIG. 104, showing the needle tip 11being safely contained within the needle guard 22 a with the arm 45 andprojection 42 correspondingly moved inwardly and activated with theneedle trap 41, including a few different versions of the components:said tether 24 being fixedly attached to the housing 85, said housing 85having at least one longitudinal nonslip projection 86, said housinghaving a distal projection 90 which may snap over said needle guard 22 awhen said needle guard 22 a is contained within said housing 85, saidneedle guard 22 a having a split line 43, said projection 42 having a“v” shape. The shape of the projection 42 is not limited to a singularor double faced surface, but might be oval, round, radial, smooth orrough or a combination of any surfaces described herein.

FIG. 106 is a cross-sectional and cut away side view of the presentinvention ready for use on a male luer syringe shows a full view of thehypodermic needle 10 having a change in profile 3 near the distal endfor limiting axially movement of a slidable needle guard 22 relative tothe needle tip 11 after positioning said needle guard 22 at the distalend of the needle 10 comprising: a hub 12 with a fixedly attached needle10, a means for retaining a separate, movable needle guard 22, saidneedle guard 22 having an aperture therethrough for said hypodermicneedle 10, whereby the needle guard 22 is retained in a ready to useposition on said hub 12, with said retained needle guard 22 being urgedaway from said needle hub 12 by a compressed resilient member 19, saidresilient member 19 being located between, among or amid said hub 12 andsaid needle guard 22, said resilient member 19 also being located in anannular fashion surrounding a portion of said needle guard 22.

Said hub 12 having an aperture therethrough creating a fluid/gas path tosaid hypodermic needle 10, at least one flange 101 for attaching theneedle hub 12 to a male luer fitting, a needle nest 4 for fixedlyattaching the needle 10, said needle 10 a sharpened distal end 11 and anunsharpened proximal end being fixedly attached to said hub 12 and anintegral hub portion 15 having a protrusion 5 located at the distal endof said hub body 15, said protrusion 5 being connected to the hubportion 15, said hub portion 15 also having a section 16 for removablyattaching a protective storage cover, a moveable latching arm or lever26 with a touch pad 27 attached to the hub portion 15 by a hinge section23, with the moveable latching arm 26 having a protrusion 21 forretaining a component in a releasably retained position on the hubportion 15, said latching arm 26 also having a protrusion 49 for biasingthe latching arm 26 in an outward manner when a compressive force isapplied to the releasably held needle guard 22; and a movable needleguard 22 having a proximal guide section 34, a distal needle guidesection 47 and a movable needle trap 41 (not shown in this view), areceiving slot 31 to receive the needle trap, a retaining area 44 a withan aperture 48 to receive said protrusion 21, said needle guard 22having a compressed resilient member 19 positioned at the proximal endof said needle guard 22 said with the resilient member 19 exerting anextending force on said needle guard 22; with said needle guard 22 beingreleasably held in a compressed position by the hook 21 of the moveablelatching arm 26 on said hub portion 15, an aperture for orienting saidneedle guard assembly 22 adjacent to said hub portion 12, said aperturehaving the hub protrusion 5 positioned therethrough, said latching arm26 having a protrusion 49 for engaging said needle guard 22 when saidneedle guard 22 is urged toward said hub portion 12, said needle guard22 engages protrusion 49 and manually moves said latching arm 26 in anoutward manner ensuring said latching arm 26 moves outwardly releasingthe hold on the needle guard 22.

FIG. 107 is a cross sectional and cut away top view of FIG. 106containing the elements shown and described in FIG. 106 with thereleasably held needle guard assembly 22 (shown in a partial cut awayview) being releasably held adjacent to said hub portion 15, said guardassembly 22 being movable by the stored energy present in the compressedresilient member 19, said resilient member 19 being slidably retained onsaid needle guard 22 by the notch or indentation 60, said movable needletrap 41 having a lead-in area 33 for locating said resilient member 19on said needle guard 22 into notches 60 and/or 61, said needle trap 41also having at least one notch or indentation 61 for releasablyretaining said end coils of said resilient member 19, said needle guard22 having a proximal guide section 34, a distal needle guide aperture47, a needle trap 41 biasly contacting said hypodermic needle 10 by theinherent memory of the molded configuration of said needle trap 41and/or the extending force of the surrounding resilient member 19,whereby the advancing movement of said needle guard 22 is limited by achange in profile 3 of said needle 10, said needle 10 having a sharpeneddistal end 11 and an unsharpened proximal end being fixedly attached tosaid hub 12.

Said needle 10 being fixedly attached to hub 12 in a needle nest 4, saidhub 12 having a flange 16 for removably attaching a protective cover,and at least one flange 101. Said needle trap 41 being hingedly attachedto said needle guard 22 by a hinge section 40, said needle guard 22having a receiving slot 31 to receive the needle trap 41.

FIG. 108 is a cross sectional and cut away top view FIGS. 106 and 107showing the needle tip 11 being trapped within the needle guard 22 bythe movable needle guard 41, comprising a hypodermic needle 10 having asharpened tip 11, said needle guard 22 being limited in its axialmovement by means of a change in profile 3 near the distal end of saidneedle 10, with the resilient member 19 extended and maintaining anextending force on the needle guard assembly 22, said needle guard 22 isprevented from advancing further by the limiting feature of said changein profile 3, said resilient member 19 being slidably retained on saidneedle guard 22 by the notch or indentation 60, said movable needle trap41 having a lead-in area 33 for locating said resilient member 19 onsaid needle guard 22 into notches 60 and/or 61, said needle trap 41 alsohaving at least one notch or indentation 61 for releasably retainingsaid end coils of said resilient member 19, said needle guard 22 havinga proximal guide section 34, a distal needle guide aperture 47, a needletrap 41 biasly contacting said hypodermic needle 10 by the inherentmemory of the molded configuration of said needle trap 41 and/or theextending force of the surrounding resilient member 19, whereby theadvancing movement of said needle guard 22 is limited by a change inprofile 3 of said needle 10, said needle 10 having a sharpened distalend 11 and an unsharpened proximal end being fixedly attached to saidhub 12. Said needle 10 being fixedly attached to hub 12 in a needle nest4, said hub 12 having a flange 16 for removably attaching a protectivecover, and at least one flange 101. Said needle trap 41 being hingedlyattached to said needle guard 22 by a hinge section 40, said needleguard 22 having a receiving slot 31 to receive the needle trap 41.

Said proximal guide 34 is shown here maintaining the needle guard 22 ina substantially concentric manner on said hypodermic needle 10. Saidneedle guard 41 also having a tapered or reducing proximal section 304for non-binding access by the movable resilient member 19.

FIG. 109 is a full top view of a needle guard 22 having a proximal guidesection 34, a reducing section 304, a longitudinally shaped chamber 94,a projection 63 to allow free movement of a movable latch, and a distalguide section 47. This embodiment utilizes a separate needle guardcomponent.

FIG. 110 is a full front view of a needle guard 22 shown in FIG. 109,having a longitudinal chamber 94, a slot 25 to accept a latching means,a distal guide section 47, and an aperture.

FIG. 111 is a cross sectional view of the needle guard 22 shown in FIG.109 along axis 111-111 showing the slotted configuration, of chamber 94.

FIG. 112 is a full bottom view of a needle guard 22 shown in FIG. 109having a notch 60, a reducing section 304 and a projection 63 to allowfree movement of a movable latch.

FIG. 113 is a full rear view of the movable needle guard 22 shown inFIG. 112 having a chamber 94, an aperture, a notch 60 and a proximalguide section 34.

FIG. 114 is a full top view of the needle guard 220 for a catheterintroducer having an inner chamber 94, a proximal guide section 34, arecess 31 to receive a movable needle trap, a middle guide section 93for locating a needle 10 during assembly procedures, a slot 80 forreceiving the proximal end of a separate needle trap 41, a slottedcatheter adapter 78, a distal guide section 92, and a projection 91 forreleasably holding a catheter hub 13 in a specific orientation on saidneedle guard 220.

FIG. 115 is a full front view of the needle guard 220 for a catheterintroducer shown in FIG. 114 having a middle guide section 93 forlocating a needle 10 during assembly procedures, a slotted catheteradapter 78, a distal guide section 92, and a projection 91 forreleasably holding a catheter hub 13 in a specific orientation on saidneedle guard 220. Said needle guard 220 having a needle 10 therethrough,said needle being contained through said needle guard 220 by theseparately attached needle trap 41. Said needle 10 being concentricallylocated through said needle guard 220 located by the needle trap 41.

FIG. 116 is a cross sectional and cut away side view of a separateneedle trap 41 having a proximal side 82 which inserts into a slotwithin a slidable needle guard. Needle trap 41 includes a least oneprojection 83 for fixedly attaching said needle trap in a needle guard,a lead in side 33 for locating a resilient member during assemblyprocedures, a notch 61 for maintaining an extending force of saidresilient member on said trap 41, and a plurality of sides or skirts 46to contain a sharpened tip 11 of a needle 10 within said trap 41. Saidneedle trap 41 can comprise plastic, metal, or any other substantiallyimpenetrable material.

FIG. 117 is a full top view of the housing 85 having a lip 90 andinternal fins 97. Said fins 97 can be eliminated by shaping the crosssection of said housing 85 to match the housing shape shown in FIG. 120.

FIG. 118 is a cross sectional and cut away top view of a catheterintroducer comprising the components shown and described in FIG. 114,having a needle 10 with one sharpened distal end 11, said needle 10having a change in profile 3 near the distal end of said needle 10, saidneedle 10 being fixedly attached to a hub 9 by a needle nest 4, said hub9 having a flange or plurality of projections 16 to accept a removablestorage cover, said needle 10 having a needle guard 220 being slidablydisposed about said needle 10 and initially positioned adjacent to theproximal end of said needle 10. Said needle guard 220 having a receivingslot 31 for a movable needle trap 41, a slot 80 for fixedly attaching aseparate needle trap 41, a catheter adapter 78, and a proximal guidesection 34. Said needle trap 41 having a proximal side 82 which isreceived in said slot 80, a plurality of sharp projections 83 forfixedly attaching said needle trap 41 on said needle guard 220 into slot80, an extending arm 45 and a projection 42 for releasably holding acatheter hub 13 adjacent to said needle guard 220, said side 82 having aguide section 84 for locating said needle centrally through said guard220. Said separable catheter 29 having a hub 13 and an inner channel,recess, slot or undercut 32 for being releasably held by said movablearm 42. This embodiment still side loads onto a needle, leaving thedelicate tip untouched and sharp.

FIG. 119 is a full top view of the separate needle trap 41 for a syringeor blood collecting assembly, comprising a needle trap 41, a pluralityof skirts 46, each created by a fold, a notch 61, a lead in section 33,a proximal side 82, created by a fold, having a plurality of sharpprojections 83 and a guide section 84. Notch 61 and lead in section 33are optional.

FIG. 120 is a cross sectional and cut away top view of a catheterintroducer ready for use comprising the components shown and describedthroughout this application, having a needle 10 with one sharpeneddistal end 11, said needle 10 being fixedly attached to a hub 9 by aneedle nest, said hub 9 having a lead in area 38 for concentricallylocating a movable housing 85 onto said needle 10, a flange or pluralityof projections 16 to accept a removable storage cover, said needle 10having a needle guard 22 a being slidably disposed about said needle 10and initially positioned adjacent to the proximal end of said needle 10.Said hub 9 also having a distal hub section 15 and a flashback chamberlocated at the distal end of said hub 9. Said flashback chamber beingclosed by means of a removable plug 100.

This drawing shows said needle guard 22 a being held within a housing orshroud 85, said housing having a tapered configuration, allowing forconcentric placement of said resilient member within said housing and animproved gripping means by the user. Said housing 85 having an innerchamber for receiving a resilient member 19 and a slidable needle guard22 a, said housing 85 may also have exterior serrations or channelsserving as a non-slip gripping means. Said needle guard 22 a being heldwithin said housing 85 by a snap-fit means created by the wedge 66 a andslot 66 b at the proximal end of said needle guard 22 a. Said housing 85having a curb 90 serving as a gripping means, and a corresponding,proximal aperture to receive said wedge 66 a and slot 66 b, saidaperture having a “lead-in” 96 for easy assembly of said guard 22 a intosaid housing 85.

Said housing 85 and resilient member 19 are assembled onto the needle 10by an over the needle 10 procedure. The proximal aperture of saidhousing 85 is substantially larger than the needle 10 diameter, allowingthe housing 85 to easily be assembled onto the needle 10 withouttouching the delicate tip 11. A means to automatically andconcentrically locate the housing 85 on the needle 10 is described inthis application. The proximal guide section 34 of the needle guard 22 ais only slightly larger than the needle 10 diameter, allowing a close,concentric fit necessary for the invention to function properly. Theneedle guard 22 a is loaded onto the needle 10 from the side and oncethe clam shell guard 22 a is closed, the concentrically located needleguard 22 a slides down the needle 10 shaft and snap fits into theconcentrically located housing 85 and resilient member 19. The side loadguard 22 a also works in the same concentric manner once the separateneedle trap 41 is fixedly attached to the needle guard 22 a once theguard 22 a and trap 41 are concentrically located on the needle 10shaft.

Said needle guard 22 a comprising a clam-shell design having a splitline 43, a receiving slot 31 for a movable needle trap 41, a distalcatheter adapter 78, and a proximal guide section 34 (shown in otherdrawings in this application). Said needle trap 41 having an extendingarm 45 and a projection 42 for releasably holding a catheter hub 13adjacent to said needle guard 22 a. Said separable catheter 29 having ahub 13, an inner channel, recess, slot or undercut 32 for beingreleasably held by said movable arm 45 and projection 42, and aplurality of flanges 301 to twistedly attach said hub 13 to a luerfitting.

Said slidable needle guard 22 a being fixedly attached to a hub portion9 by means of a limiting tether 24, said tether 24 being fixedlyattached to said needle guard 22 a by means of an extension 28. Saidneedle guard 22 a having a notch or indentation 60 for releasablyholding said resilient member 19 on said needle guard 22 a, said movableneedle trap 41 having a lead-in area 33 for locating said resilientmember 19 on said needle guard 22 a into notches 60 and/or 61, saidneedle trap 41 also having a notch or indentation 61 for retaining saidend coils of said resilient member 19, with the distal end of saidneedle guard 22 a having a male section 78 for removably attaching anindwelling I.V. catheter hub 13, said needle trap 41 having a movablearm 45 and projection 42 for releasably retaining a catheter hub 13 fromsaid adapter section 78 after insertion of the catheter 29 into apatient. Said catheter hub 13 having at least one flange 301 and aninner channel, recess, slot or undercut 32 for being releasably held bysaid movable arm 45 and said projection 42.

Said needle guard lead in 33 section on said needle trap 41 could alsocomprise longitudinal channels to reduce the contact surface area ofsaid resilient member, reducing frictional contact and reducing theamount of material used to manufacture the component.

FIG. 121 is a cross sectional and cut away top view of a catheterintroducer safely trapping the needle tip 11 after the catheter 29 hasbeen inserted into a patient, comprising a needle 10 with one sharpeneddistal end 11, said needle 10 being fixedly attached to a hub 9 by aneedle nest 4, a flange of plurality of projections 16 to accept aremovable storage cover, said needle 10 having a needle guard 22 a beingslidably disposed about said needle 10 and said needle tip 11 beingsafely positioned within said needle guard 22 a. Said hub 9 also havinga distal hub section 15 and a flashback chamber located at the distalend of said hub 9. Said flashback chamber being closed by means of aremovable plug 100. Said hub 15 having a lead in area 38 forconcentrically locating a movable housing 85 onto said needle 10.

FIG. 121 shows needle guard 22 a being held within a housing or shroud85 having an integral resilient member 19. Said housing 85 having aninner diameter which locates the compressed resilient member 19 on thenotches 60 and/or 61 on said needle guard 22 a, said housing 85 may alsohave exterior serrations or exterior channels serving as a non-slipgripping means, and a proximal skirt 99 which contacts said hub 15during assembly, allowing said needle guard 22 a to be pressed into saidhousing 85.

Said needle guard 22 a being held within said housing 85 by a snapfitmeans created by the wedge 66 a and slot 66 b at the proximal end ofsaid needle guard 22 a. Said wedges 66 a may have a longitudinal opening81 at the split line 43 to allow said wedges 66 a to compress as saidneedle guard 22 a is snap fit into said housing 85. Said housing 85 mayalso have a distal curb 90, described in FIG. 105, serving as a grippingmeans, and a corresponding proximal aperture to receive said wedge 66 aand slot 66 b, said proximal aperture having a “lead-in” 96 for easyassembly of said guard 22 a into said housing 85. Said housing 85 iscentrally located onto said needle 10 by an over the needle procedure.Said housing 85 having a proximal skirt 99 with an internal annularchamfer for concentrically locating said housing 85 onto said needle 10and hub 9 by means of chambered configuration of said needle nest 4.Said skirt 99 is not necessarily needed to implement the presentinvention.

Said needle guard 22 a comprising a clam-shell configuration having asplit line 43, a receiving slot 31 for a movable needle trap 41, adistal catheter adapter 78, and a proximal guide section 34 (shown inother drawings in this application). Said needle trap 41 having anextending arm 45 and a projection 42 for releasably holding a catheterhub 13 adjacent to said needle guard 22 a. Said separable catheter 29having a hub 13, undercut 32 for being releasably held by said movablearm 45 and projection 42, and a plurality of flanges 301 to attach saidhub 13 to a luer fitting.

Said undercut 32 can be annular or segmented and still provide a holdingmeans to keep said catheter hub 13 adjacent to said needle guard 22 auntil said needle tip 11 is fully contained within said needle guard 22a.

Said slidable needle guard 22 a being fixedly attached to a hub portion9 by means of a limiting tether 24, said tether 24 being fixedlyattached to said needle guard 22 a by means of a extension 28 or thelike. Said needle guard 22 a having a notch or indentation 60 forreleasably holding said resilient member 19 on said needle guard 22 a,said movable needle trap 41 having a lead-in area 33 for locating saidresilient member 19 on said needle guard 22 a into notches 60 and/or 61,said needle trap 41 also having a notch or indentation 61 for retainingsaid end coils of said resilient member 19, with the distal end of saidneedle guard 22 a having a male section 78 for removably attaching anindwelling I.V. catheter hub 13, said needle trap 41 having a movablearm 45 and projection 42 for releasably retaining a catheter hub 13 fromsaid adapter section 78 after insertion of the catheter 29 into apatient. Said catheter hub 13 having at least one flange 301 and anundercut 32 for being releasably held by said movable arm 45 and saidprojection 42.

FIGS. 122A, 122B and 122C show an isometric view of the catheterdescribed in FIGS. 120 and 121 as the catheter adapter 9 is separatedfrom catheter 29.

FIG. 123 is a full top view of the separate needle trap 41 for theindwelling catheter invention, comprising a needle trap 41, a pluralityof skirts 46, each created by a fold or bend, a notch 61, a lead insection 33, a proximal side 82, created by a fold or bend, having aplurality of sharp projections 83 and a guide section 84, a ledge, orretainer 27 created by at least one fold or bend, an extending arm 45,created by a fold or bend, and a projection 42, created by a fold orbend.

FIG. 124 is a full and cut away view of FIG. 123 comprising a separateneedle trap 41 for the indwelling catheter invention, comprising aneedle trap 41, a plurality of skirts 46, each created by a fold orbend, a notch 61, a lead in section 33, a proximal side 82, created by afold or bend, having a plurality of sharp projections 83, a ledge, orretainer 27 created by a fold or bend, an extending arm 45, created by afold or bend, and a projection 42, created by a fold or bend.

FIG. 125 is a is a full, outside, top view of the needle guard assembly22 a for an indwelling catheter shown in its molded configurationcomprising a foldable, open-faced needle guard 22 a having an extendedmounting section 28, a catheter adapter 78, a notch 60 for positioningand maintaining the extending force of a resilient member 19 (not shown)on said needle guard 22 a when said guard 22 a is in a retained andextending mode, and a wedge 66 a and slot 66 b at the proximal end ofsaid needle guard 22 a. Said needle guard 22 a having a movable needletrap 41 being hingedly attached to said needle guard 22 a by a hinge 40,said needle trap 41 having an extended arm 45 and projection 42 forreleasably retaining a catheter hub from said adapter 78 after insertionof the catheter 29 into a patient. Said needle trap 41 also having atleast one notch or multi-level landing 61 for proper positioning of aresilient member 19 (shown in other drawings in this application), saidneedle trap 41 having a lead in area 33 also for locating said resilientmember 19 in a compressed and/or extendible position. Said needle guard22 a being fixedly attached to a tether 24, said tether 24 having atleast one protrusion 20 for fixedly attaching said tether 24 to said hubportion 15 or hub 12, or flange 16.

FIG. 126 is a is a full, inside face view of the needle guard assembly22 a for an indwelling catheter shown in its molded configurationcomprising a foldable, open-faced needle guard 22 a having an extendedhinge section 28, a wedge 66 a and slot 66 b located at the proximal endof said needle guard 22 a, said needle guard 22 a having a movableneedle trap 41 being hingedly attached to said needle guard 22 a by ahinge 40, said needle trap 41 having an extended arm 45 and projection42 for releasably retaining a catheter hub from said adapter 78 afterinsertion of the catheter into a patient. Said needle guard 22 a alsohaving a proximal guide section 34 and a distal guide section 47, whichare created when the needle guard 22 a sections are joined together,said needle guard 22 a also having a middle guide section 93. Saidneedle guard 22 a having a movable needle trap 41 being hingedlyattached by the hinge 40, said needle trap 41 having at least one skirtor fin 46 for entrapping said sharpened needle tip 11 (shown in otherdrawings in this application), said needle guard 22 a having acorresponding slot or opening 31 for receiving said needle trap 41, saidneedle guard 22 a having at least one pin 36 and a corresponding opening37 for frictionally engaging or snap fitting said needle guard 22 asections together about the hypodermic needle 10 (as shown in previousdrawings) said pin 36 and slot 37 can be positioned on either side ofneedle guard 22 a sections, said needle guard 22 a having an internalguide section 35 and a proximal guide section 34, said needle guard 22 ahaving an internal landing 52 located between said internal guide 35,with said landing 52 having an adjacent landing 53 which serves to guidesaid hypodermic needle 10 (shown in other drawings in this application)during assembly, storage and use, said landing 53 also houses saidsharpened needle tip 11 (shown in other drawings in this application)within said needle guard 22 a.

Said needle guard 22 a being fixedly attached to an integral, orseparate, tether 24. Said tether 24 connects to a hub 15 (not shown).

FIG. 127 is a full front view of the clam shell needle guard assembly 22a for an indwelling catheter shown in an open-faced configurationcomprising a needle guard assembly 22 a having a movable needle trap 41,said needle trap 41 having an extended arm 45 and a projection 42, aninternal guide section 35, a distal catheter adapter 78, an extendedhinge section 28, with a plurality of needle guard 22 a sectionsconnected adjacent to said hinge section 28, said hinge section 28having an adequate area for insert molding a separate tether or fixedlyattaching said separate tether 24, said hinge section 28 also could havean aperture therethrough for fixedly inserting a separate tether 24.Said needle guard 22 a having a split line 43 where the needle guard 22a sections mate or join together, an aperture guide 47 on each sectionat the distal end, and a post 36 for joining the needle guard assembly22 a sections together. Said post 36 is received by a corresponding slotor opening 37 on the adjacent half of said needle guard 22 a.

FIG. 128 is a full rear view of the needle guard assembly 22 a for anindwelling catheter shown in an open-faced configuration comprising aneedle guard assembly 22 a having an extended hinge 28 for joining eachneedle guard 22 a section together, said extended hinge section 28having a slot or recess for inserting a fixedly attached, or separatetether (not shown). Said needle guard 22 a also having an internal guidesection 35, a split line 43 where the needle guard 22 a sections mate orjoin together, a proximal guide 34 and proximal wedge projection 66 alocated on each needle guard 22 a section, a moveable needle trap 41, atleast one post or protrusion 36 on one needle guard assembly 22 asection which enters at least one corresponding slot 37 on the otherneedle guard assembly 22 a section for securing the sections together.Said post 36 is received by a corresponding slot or opening 37.

FIG. 129 is a cross sectional view of the needle guard 22 a in FIG. 126shown along axis 129-129 and comprising a needle guard section 22 a, aninternal guide section 35 having an angled face to concentrically locatesaid hypodermic needle through said needle guard 22 a, a landing 52 anda split line 43.

FIG. 130 is a cross sectional view of the disclosed needle guard 22 a inFIG. 126 shown along axis 130-130 and comprising a needle guard section22 a, and a needle trap 41 having a plurality of skirts or wall sections46.

FIG. 131 is a full side view of the hollow bore needle 10 of the presentinvention having an expanded change in profile 3 and a sharpened, distaltip 11.

FIG. 132 is a full top view of the disclosed hollow bore needle 10having a reduced change in profile 3 a and a sharpened, distal tip 11.

FIG. 133 is a full side view of the disclosed hollow bore needle 10 inFIG. 131 having an expanded change in profile 3 and a sharpened, distaltip 11 and a slidable washer or bushing 130 adjacent to said expandedchange in profile 3. Washer 130 is limited in axial movement by largersize of expanded change in profile 3.

FIG. 134 is a cross sectional side view of FIG. 133 comprising a hollowbore needle 10 having an expanded change in profile 3 and a sharpened,distal tip 11 with a slidable washer or bushing 130 having an aperture131 sized to allow washer 130 to slide axially on needle 10, but axialmovement of washer 130 on needle 10 is limited by the expanded change inprofile 3 because the aperture 131 is smaller than the change in profile3.

FIG. 135 is s full front view of washer or bushing 130 having anaperture 131.

FIG. 136 is a cross sectional and cut away side view of the needle guardassembly of the present invention showing the needle tip 11 beingtrapped within the needle guard 22 by the movable needle guard 41,comprising a hypodermic needle 10 having an expanded change in profile 3and sharpened tip 11, said needle guard 22 being limited in its axialmovement by engagement of bushing or washer 130 with expanded change inprofile 3 near the distal end of said needle 10, said washer beingretained by slot 132 in needle guard 22, with the resilient member 19extended over movable needle trap 41 and maintaining said needle trap 41in a locked position. Said needle trap 41 being hingedly attached tosaid needle guard 22 by a hinge section 40, said needle guard 22 havinga receiving slot or nest 31 to receive the needle trap 41.

Said proximal guide 34 and washer 130 are shown here maintaining theneedle guard 22 in a substantially concentric manner on said hypodermicneedle 10. Said needle guard 41 also having a tapered or reducingproximal section 304 for non-binding access by the movable resilientmember 19.

FIG. 137 is a cross sectional and cut away side view of the needle guardassembly 22 shown in FIG. 136 showing the needle tip 11 being trappedwithin the needle guard 22 by the movable needle trap 41, said needletrap having a rib or protrusion 133 to closely contain said needle 10within needle guard assembly 22, comprising a hypodermic needle 10having an expanded change in profile 3 and sharpened tip 11, said needleguard 22 being limited in its axial movement by engagement of bushing orwasher 130 with expanded change in profile 3 near the distal end of saidneedle 10, said washer being retained by slot 132 in needle guard 22,with the resilient member 19 extended over movable needle trap 41 andmaintaining said needle trap 41 in a locked position. Said needle trap41 being hingedly attached to said needle guard 22 by a hinge section40, said needle guard 22 having a receiving slot or nest 31 to receivethe needle trap 41.

FIG. 138 is a cross sectional front view of the needle guard assembly 22shown in axis 138-138 of FIG. 137 showing the needle 10 being trappedwithin the needle guard 22 by the movable needle trap 41, said needletrap having a rib or protrusion 133 to closely contain said needle 10within needle guard assembly 22.

FIG. 139 is a full front view of the needle guard assembly 222comprising an off set split line 143 creating aperture 147 that needle10 can slide through, and a corresponding needle guard section 223.

FIG. 140 is a full side view of a prior art needle 310 having ananti-coring tip 311 and a bend, or change in axis, 303 on needle shaft310.

FIG. 141 is a cross sectional side view of needle 310 being covered withslidable housing 322, said needle 310 having an anti-coring tip 311 anda bend, or change in axis, 303 at a position on the needle shaft 310that limits axial movement of housing 322 on shaft 310, said housing 322having a distal opening 347, a proximal guide shaft 334 that is sized toslide on shaft 310, said housing 322 is limited in axial movement onshaft 310 by proximal guide 334 engaging bend 303. Said proximal guide334 being sufficient to limit axial movement of housing 322 on needle310.

FIG. 142 is a cross sectional side view of needle 310 having ananti-coring tip 311 and a bend, or change in axis, 303 in the needleshaft 310 that limits axial movement of bushing 313 on shaft 310. Aneedle guard assembly as shown in FIGS. 136 and 137 may include bushing313 to limit axial movement of a needle guard assembly on shaft 310.

FIG. 143 is a cross-sectional side view of the needle guard assembly ofthe present invention showing the interaction of the needle guardassembly 322 and resilient member 319, said hypodermic needle 310 havingan anti-coring sharpened needle tip 311 and a change in axis 303,comprising a slidable needle guard assembly 322 with a hypodermic needle310 therethrough, with resilient member 319 urging the needle guardassembly 322 toward the distal end of the hypodermic needle 310. Theneedle guard assembly 322 having proximal guide section 334, a movableneedle tip guard 341 with a hinge section 340, said needle tip guard 341is molded in a manner whereby the needle tip guard 341 comprises aninherent biasing force toward the hypodermic needle 310, another biasingforce is exerted on the needle tip guard 341 by the extending force ofthe resilient member 319, said needle tip guard 341 enters thecorresponding recess 331 when said needle tip guard 341 advances beyondthe sharpened needle tip 311, said needle tip guard 341 slidablycontacts said hypodermic needle 310.

FIG. 144 is cross-sectional side view of the needle guard assembly shownin FIG. 143 showing containment of the sharpened needle tip 311 withinthe needle guard assembly 322 comprising a needle guard assembly 322with a hypodermic needle 310 therethrough, said needle guard assembly322 being urged beyond the distal end of the hypodermic needle 310 andsharpened needle tip 311 by the extending force of a resilient member319 whereby the moveable, self-biasing needle tip guard 341 of theneedle guard assembly 322 moves in front of the sharpened needle tip311, containing the sharpened needle tip 311 within the needle guardassembly 322 and behind the substantially impenetrable needle tip guard341 having a hinge section 340. The needle guard assembly 322 havingproximal guide section 334 that engages bend in needle 303 to limitaxial movement of needle guard 322 on needle 310.

Additionally, the extending force of the resilient member 319 urges theneedle tip guard 341 inwardly to a covering position, said resilientmember 319 surrounds both the needle guard assembly 322 and the outerwall of the needle tip guard 341 holding the needle tip guard 341 in aclosed, protective position by a radially confining force. In theprotected, closed position, the needle tip guard 341 enters thecorresponding recess 331 of the needle guard assembly 322, preventingmovement and ensuring safe containment of the sharpened needle tip 311within the needle guard assembly 322.

FIG. 145 is a full side view and cut away drawing of the needle hub ofthe present invention comprising a hypodermic needle hub 612 with atleast one flange 601 for attaching the needle hub 612 to a luer fitting,a needle nest 604 (not shown in this view) for fixedly attaching theneedle (not shown in this view), an inner aperture 616 (not shown inthis view) creating a fluid/gaseous path between needle hub 612 andneedle 610 (not shown in this view), at least one aperture 644 locatedat the distal end of a deformable housing 615 for receiving a protrusionfor releasably retaining a member on needle hub 612, said housing 615having an inner cavity or chamber 617 and deformable wall section 650.

FIG. 146 is a full front view drawing of the needle hub of FIG. 145comprising a deformable housing 615 having an inner aperture 616 forcreating a fluid/gaseous path between hub 612 (not shown in this view)and a hypodermic needle 610 (not shown in this view), said housing 615having an inner cavity or chamber 617 and deformable wall section 650.

FIG. 147 is a full top view drawing of the needle hub of FIG. 145comprising a hypodermic needle hub 612 with at least one flange 601 forattaching the needle hub 612 to a luer fitting, at least one aperture644 located at the distal end of a deformable housing 615 for receivinga protrusion for releasably retaining a member on needle hub 612.

FIG. 148 is a full top view drawing of a ready to use needle apparatusof the present invention showing needle guard 622 being releasablyretained in deformable housing 615 by engagement of protrusion 645 ofneedle guard 622 into aperture 644 of deformable member or housing 615,comprising a hypodermic needle hub 612 with at least one flange 601 forattaching the needle hub 612 to a luer fitting. Said needle guard 622may include a resilient member (not shown in this view) to propel needleguard 622 to the distal end of needle 610.

FIG. 149 is a full front view of the needle guard assembly 622 of FIG.148 comprising at least one protrusion 645, an off set split line 643creating aperture 647 and a corresponding needle guard section 623.

FIG. 150 is a full front view of the needle guard apparatus of thepresent invention comprising needle guard assembly 622 being releasablyretained within deformable member or housing 615, said housing having acavity or chamber 617 for accepting a member or guard, said needle guardassembly 622 comprising a passageway for needle 610, at least oneprotrusion 645, an off set split line 643 creating aperture 647 and acorresponding needle guard section 623, said deformable housing 615having at least one aperture 644 located at the distal end for receivingand releasably retaining protrusion 645 of needle guard assembly 623within cavity 617 of housing 615.

FIG. 151 is a full front view of the needle apparatus of FIG. 150showing the needle guard assembly 622 being selectively released when acompressive force “F” is exerted on deformable housing 615, said needleguard assembly 622 comprising a passageway for needle 610, at least oneprotrusion 645 that is released from aperture 644 (not shown in thisview) when deformable housing 615 is squeezed. Said needle guardassembly having an off set split line 643 creating aperture 647 creatinga passageway for needle 610, and a corresponding needle guard section623, said deformable housing 615 having at least one aperture 644located at the distal end for releasably retaining protrusion 645 ofneedle guard assembly 623 within cavity 617 of housing 615.

FIG. 152 is an isometric view of the needle guard assembly 622 ready tousereleasably being retained within deformable housing 615 having adeformable wall section 650, said housing 615 being selectivelyattachable to hub 602 having a luer end 601, said needle guard assembly622 comprising a movable trap 641, a passageway for needle 610 with asharpened tip 611 and a change in profile 603, at least one protrusion645 (shown retained within aperture 644 of housing) on section 623, anoff set split line 643 creating aperture 647 and corresponding needleguard section 623, said deformable housing 615 having at least oneaperture 644 located at the distal end for receiving said protrusion 645of corresponding needle guard assembly 623. Said housing 615 having aninner guide or rib 651 to properly position needle guard 622 within hub615, said housing 615 being selectively attached to hub 602 by aretaining means or hook 613 and may include at least one rib 625 forgripping said housing 615. Needle guard 622 is released from a retainedposition by squeezing deformable housing 615 and guard 622 is propelledalong the needle 610 by resilient member 619.

FIG. 153 is an isometric view of the needle guard assembly of FIG. 152showing containment of the sharpened needle tip 611 within the needleguard assembly 622, said needle guard assembly 622 comprising a movabletrap 641 that is locked in a protective position on needle tip 611,needle guard 622 is limited in axial movement by engagement of needleguard 622 with change in profile 603 of needle 610.

A number of embodiments have been disclosed herein as they relate to theneedle protective device of the present invention. It is important tounderstand that many of the elements described herein may beinterchangeable. It is also important to note that the invention cancomprise a variety of embodiments, ranging from a single piece,injection molded part, where the components are manufactured unitarily,to a plurality of components, all which achieve the desired result ofsafely capturing the sharpened needle tip.

1-13. (canceled)
 14. A method of inserting a needle within a patientcomprising the steps: a) providing a needle protective device, theneedle protective device comprising: i) a needle defining proximal anddistal ends; ii) a needle guard mounted about the needle and traversablebetween the proximal and distal ends of the needle, the needle guardbeing biased to the distal end of the needle, the needle guard having atleast one protrusion; and iii) a housing fixed to a proximal end of theneedle and sized and configured to receive the needle guard, the housinghaving at least one aperture sized and configured to receive the needleguard protrusion when the needle guard is at the proximal end of theneedle; b) inserting said distal end of said needle provided in step a)within said patient; and c) manually manipulating said housing such thatthe needle guard received therein is urged therefrom and biased to thedistal end of the needle.
 15. The method of claim 14 wherein in step a),the needle guard defines a circular outer diameter, and the housing hasan inner elliptical configuration defining a minor axis equal to theouter diameter and a major axis, the aperture of the housing beingaligned with the minor axis of the housing such that application of acompressive force on the major axis expands the minor axis to disengagethe protrusion from the aperture.
 16. The method of claim 15 wherein instep a), the housing is deformable and wherein in step c) comprisesdeforming said housing.
 17. The method of claim 16 wherein the housingis manufactured from material selected from the group consisting ofplastic, rubber and combinations thereof.
 18. The method of claim 14wherein step a) further comprises providing a guide attached to thehousing to stabilize lateral movement of the needle guard within thehousing.
 19. The method of claim 14 wherein sstep a) further comprisesproviding a resilient member mounted about the needle and disposedbetween the housing and the needle guard to bias the needle guard to thedistal end of the needle.
 20. The method of claim 19 wherein in step a),the needle guard defines a flange and a base, and the resilient memberexerts a force on the base to propel the needle guard to the distal endof the needle then on the flange to maintain a moveable trap within theneedle guard.
 21. The method of claim 20 wherein in step a), theresilient member is a compression spring.
 22. The method of claim 21wherein the base has a conical configuration for guiding the springabout the base as the spring is being compressed.